Ronald Bentley
PFD Report
Partially Responded
Ref: 2016-0086
Coroner's Concerns (AI summary)
A previously unrecognised risk of air entering the vascular system during a cardiac procedure with conscious sedation was identified, highlighting a critical lack of awareness and necessary safeguards across cardiac centres.
View full 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. 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.
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.
Responses
Noted
The British Cardiovascular Intervention Society (BCIS) circulated the report to its members via its official newsletter and passed on details to the British Heart Rhythm Society (BHRS). (AI summary)
The British Cardiovascular Intervention Society (BCIS) circulated the report to its members via its official newsletter and passed on details to the British Heart Rhythm Society (BHRS). (AI summary)
View full response
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 can arrange for circulation to electrophysiology colleagues_
Sent To
- British Cardiac Intervention Society
- British Society of Interventional Radiology
Response Status
Linked responses
1 of 2
56-Day Deadline
28 Apr 2016
About PFD responses
Organisations named in PFD reports must respond within 56 days explaining what actions they are taking.
Source: Courts and Tribunals Judiciary
Report Sections
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.
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
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
Copies Sent To
I am also under a duty to send the Chief Coroner a copy of your response
Signature_________________________ Emma Brown Area Coroner Birmingham and Solihull
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Data sourced from Courts and Tribunals Judiciary under the Open Government Licence.