Prevention of Future Deaths reports · 2016

Ronald Bentley

Regulation 28 report to prevent future deaths, reference 2016-0086, written 3 Mar 2016. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.

Date of report3 Mar 2016
Reference2016-0086
DeceasedRonald Bentley
CoronerEmma Brown
Coroner areaBirmingham and Solihull
CategoryHospital Death (Clinical Procedures and medical management) related deaths
Sourcejudiciary.uk record · original PDF
Responses published1

The report

Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.

REGULATION 28 REPORT TO PREVENT FUTURE DEATHS
THIS REPORT IS BEING SENT TO: British Cardiac Intervention Society and the British Society
of Interventional Radiology
1 CORONER
I am Emma Brown Area Coroner for Birmingham and Solihull
2 CORONER’S LEGAL POWERS
I make this report under paragraph 7, Schedule 5, of the Coroners and Justice Act 2009 and regulations
28 and 29 of the Coroners (Investigations) Regulations 2013.
3 INVESTIGATION and INQUEST
On 25/09/2015 I commenced an investigation into the death of Ronald Reginald BENTLEY. The
investigation concluded at the end of the inquest on 25th February 2016. The conclusion of the inquest
was that the death was a result of an unforeseen complication of a medical procedure.
4 CIRCUMSTANCES OF THE DEATH
The Deceased passed away at the Queen Elizabeth Hospital Birmingham on the 20th September 2015 as
a result of a complication during an elective percutaneous closure of an atrial appendage on the 17th
September 2015. During the procedure which was being performed under conscious sedation air was
introduced into the vascular system when the Deceased took a deep breath whilst the sheath into the
left atrium was open to allow the appendage occlusion device to be introduced. This caused an air
embolism which resulted in a hypoxic brain injury. The procedure was required for the treatment of atrial
fibrillation and flutter and was being performed under conscious sedation because the Deceased had a
significant vascular lesion on his tongue and there was a concern that a tracheal tube could cause this to
haemorrhage if a general anaesthetic was used.
The medical cause of death was:
1(a) HYPOXIC BRAIN INJURY
1(b) AIR EMBOLISM SECONDARY TO LEFT HEART CATHETERISATION
2 DIABETES MELLITUS, ATRIAL FLUTTER
5 CORONER’S CONCERNS
During the course of the inquest the evidence revealed matters giving rise to concern. In my opinion
there is a risk that future deaths will occur unless action is taken. In the circumstances it is my statutory
duty to report to you.
The MATTERS OF CONCERN are as follows. –
During the inquest the Consultant Cardiologist, gave evidence that before the
procedure it had not occurred to him that in performing the procedure with conscious sedation there is a
risk that if the patient breathes deeply at the 4 or so points when the sheath is open air could enter the
vascular system. He stated that there was no warning of this risk that he was aware of at the time and he
has since made enquiries of the manufacturers of the TorqVue sheath system used, St. Jude, and they
have stated that they had not identified this as a risk of conscious sedation. has since
canvassed colleagues both nationally and internationally and this risk of the procedure when proceeding
with conscious sedation had not been identified by anyone he had spoken to. stated that as
a result of Mr. Bentley’s death the University Hospital of Birmingham NHS Trust has taken the following
stops to reduce the risk of these events arising again:
(a) all such procedures to be undertaken with a general anaesthetic unless an absolute need for
conscious sedation;
(b) ensuring that LA pressure is above 10mmHg before introducing the sheath;
(c) all exchanges on to the sheath to be done in a water bath so if suction does occur it is sterile
solution sucked not air;
(d) the amount of time the TorqVue sheath is within the left atrium has been reduced by changing
to a smaller sheath as soon as possible in conjunction with introducing the occlusion device as
soon as the left atrium is entered.
However, the Coroner’s concern is that unless this risk is widely known, and safeguards introduced as a
consequence, there continues to be a risk that patients at other Cardiac Centres could suffer the same
complication.
6 ACTION SHOULD BE TAKEN
In my opinion action should be taken to prevent future deaths and I believe you have the power to take
such action.
7 YOUR RESPONSE
You are under a duty to respond to this report within 56 days of the date of this report, namely by 28th
April 2016. I, the coroner, may extend the period.
Your response must contain details of action taken or proposed to be taken, setting out the timetable for
action. Otherwise you must explain why no action is proposed.
8 COPIES and PUBLICATION
I have sent a copy of my report to the Chief Coroner and the family of Mr. Bentley.
I am also under a duty to send the Chief Coroner a copy of your response.
The Chief Coroner may publish either or both in a complete or redacted or summary form. He may send a
copy of this report to any person who he believes may find it useful or of interest. You may make
representations to me, the coroner, at the time of your response, about the release or the publication of
your response by the Chief Coroner.
9 03/03/2016
Signature_________________________
Emma Brown Area Coroner Birmingham and Solihull

Responses

1 response published against this report on judiciary.uk. A response is a body's written reply to the coroner's concerns; publication is at the discretion of the Chief Coroner's office, so an absent response does not mean nobody replied.

Response from Bcis (PDF)
i | ii

Department of Cardiology Department of Cardiology Sussex Cardiac Centre

John Radcliffe Hospital Leeds General Infirmary Royal Sussex County Hospital

Headington Great George Street Eastern Road

Oxford Leeds Brighton

OX3 9DU LS1 3EX BN2 5DE
PC

PA to HM Senior Coroner (Birmingham & Solihull Districts)
Coroner’s Court

50 Newton Street

Birmingham

B4 6NE

Your ref: EB/LMB

27 April 2016

Dear

Re: Ronald Reginald Bentley (deceased) Regulation 28 Report

Further to you circulating the report to the British Cardiovascular Intervention Society
(BCIS) and the British Society of Interventional Radiology (BSIR), I am writing to
inform you that BCIS arranged for circulation to its members via its official
newsletter on 26 April 2016 and have also passed on details to the British Heart
Rhythm Society (BHRS) so they can arrange for circulation to electrophysiology
colleagues.

Yours sincerely,

Consultant Cardiologist
Royal Sussex County Hospital

BCIS Clinical Standards Group Lead

clo BCS, 9 Fitzroy Square, London W1T 5HW / Tel: +44 (0)20 7380 1918 / Email bcis@bcs.com / Web: www.bcis.org.uk

Company limited by guarantee, registered no 07326046. Registered charity no 1138385

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