Coroner urges action after KGH patient dies of rare PEG allergy

A coroner has asked the authorities to take action to prevent more deaths after a patient admitted to Kettering General Hospital following a heart attack died of a rare allergic reaction to equipment used in a procedure designed to save his life.

KGH have also joined the calls for clearer labelling on packaging following the tragic incident.

Assistant Coroner for Northamptonshire Philip Barlow has taken the unusual step of releasing a Report to Prevent Future Deaths following the inquest into the death of Andrew Cook.

Mr Cook suffered a heart attack on March 30, 2019, and the next day was taken into surgery for a stent procedure. But during the operation he went into anaphylactic shock triggered by an allergic reaction to polyethylene glycol (PEG). Tragically, attempts to resuscitate Mr Cook were unsuccessful and he died. He was just 53-years-old.

Mr Barlow held an inquest into Mr Cook's death in June at which expert evidence was sought.

Experienced interventional cardiologist Dr Simon Heatherington had told the inquest he had been alerted to Mr Cook's allergy and had asked staff to check all the packaging for PEG before he carried out the procedure.

Afterward he was so troubled by his patient's death that he personally checked all the ingredients in every medicine and piece of equipment used during the procedure and then approached the manufacturers Asahi Intec and Abbott to further his research. He discovered that there was PEG in the coating of the wires used during the procedure.

In his Report to Prevent Future Deaths, the coroner told the Government's Medical and Healthcare Products Regulatory Agency (MHRA) that they must respond within 56 days outlining a timetable for action that should be taken to help a recurrence of the circumstances which led to Mr Cook's death. The MHRA has now asked for help from the public to report all potential PEG allergy incidents using its yellow card scheme.

Mr Barlow's report said: "Mr Cook had a previous diagnosis of allergy to PEG (polyethylene glycol) and some of the equipment used during the procedure was coated with PEG to act as a lubricant.

"Although it was not possible to draw a conclusion on the balance of probabilities, the evidence at the inquest suggests that it might have been exposure to this PEG which caused the anaphylaxis."

The report raised three areas of concern:

1) That PEG allergy is rare but may be under-reported with more research into their effect as allergens required.

2) Whether the existence, dose and molecular weight of PEG should be made clear on medical product information. The existence of PEG in the equipment (in this case, Sion and Sion Blue guidewires manufactured by Asahi Intecc) was not apparent from the packaging or product information available to the clinicians.

3) There is inconsistency and potential confusion in naming conventions. For example, PEG can be referred to as Macrogol, polyethylene oxide, or polyoxyethylene. Names may also vary between countries and there was evidence that clinicians looking at product information in urgent situations are not aware of the various synonyms.

MHRA’s Director of Devices, Graeme Tunbridge told the Northants Telegraph: “We were saddened by the news of the death of Mr Andrew Cook and our thoughts remain with his family.

“The MHRA’s priority is patient safety. As this tragic event has shown, comprehensive labelling of the substances used in the manufacture of medical devices has a critical role to play to enable health care professionals to ensure procedures are as safe as possible for their patients. The MHRA is actively gathering the small, but accumulating amount of evidence of suspected PEG allergy following exposure through medical device use.

"The public and healthcare professionals can help us to build a clear picture of the potential risks by reporting incidents via our Yellow Card Scheme.

“This work will inform and expedite the introduction of robust regulation to ensure the risk of allergic reaction to PEG or PEG derivatives in medical devices is mitigated as far as possible in the future.”

A spokesman for Kettering General Hospital said: “We offer our sincere condolences to Mr Cook’s family. At the inquest it was clear that Kettering General Hospital staff knew of Mr Cook’s PEG allergy before the procedure and took every precaution in checking the equipment and materials to be used for PEG ingredients.

“Regrettably, PEG was not listed in the packaging of the equipment used and this is a key concern. We join the Coroner in calls for clear medical product information on all packaging to prevent such tragic events happening again.”

Medical suppliers Abbott and Ashai were both approached by this newspaper for comment but did not provide statements.

A coroner's role is to find out who the deceased was, and investigate how, when and where they died. Coroners do not apportion criminal or civil blame. On occasion, when a coroner believes that their findings may help avert similar deaths, they can issue a Report to Prevent Future Deaths compelling organisations to take action. Only one such report has been made this year in Northamptonshire.

You can read Mr Barlow's full report here.