BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALERT INTERNAL CARDIOVERSION CATHETER

    MDR report key: 6515834 · Received April 24, 2017

    Report

    Report Number
    3006044395-2017-00001
    Event Type
    Death
    Date Received
    April 24, 2017
    Date of Event
    October 5, 2016
    Report Date
    April 21, 2017
    Manufacturer
    DOT MEDICAL PRODUCTS LTD
    Product Code
    MTE
    PMA / PMN Number
    P990069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE ABSENCE OF THE CATHETER ITSELF OR A RECORD OF THE BATCH NUMBER, DOT MEDICAL HAS REVIEWED THE MANUFACTURING BATCH DOCUMENTATION FOR ALL THE ALERT INTERNAL CARDIOVERSION CATHETERS SUPPLIED TO (B)(6) HOSPITAL WHICH WOULD HAVE BEEN WITHIN SHELF LIFE AT THE TIME OF THE INCIDENT. NO ADVERSE MANUFACTURING EVENTS OCCURRED WITH ANY OF THE SUPPLIED DEVICES. THERE WERE NO MANUFACTURING CHANGES INVOLVING ANY OF THESE SUPPLIED DEVICES. THERE WERE NO CHANGES TO EITHER LABELLING OR IFU CONTENT WITH THESE DEVICES. THERE ARE NO SIMILAR INCIDENTS UNDER DOT MEDICAL OWNERSHIP SINCE 2008. DUE TO LACK OF AVAILABILITY OF THE DEVICE AND BASED ON THE INFORMATION SUPPLIED BY THE HOSPITAL, NO FURTHER INVESTIGATION IS POSSIBLE. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    THIS WAS AN ELECTIVE PATIENT WHO WAS HAVING AN AF ABLATION WHICH WAS PERFORMED. TO CONFIRM THE FUNCTIONAL EFFECT OF THE ABLATION, AN EXTERNAL CARDIOVERSION WAS UNSUCCESSFUL THEREFORE THE DECISION WAS TO PERFORM AN INTERNAL CARDIOVERSION. WITH THE STYLET FULLY ENGAGED, THE EP CONSULTANT CARDIOLOGIST ATTEMPTED TO ADVANCE THE ALERT® INTERNAL CARDIOVERSION CATHETER INTO THE PULMONARY ARTERY BUT DESCRIBES HAVING DIFFICULTY AT ALL STAGES. HE THEN USES A WHISPER GUIDE WIRE¿ BUT CONTINUES TO HAVE DIFFICULTY. THE NURSE IDENTIFIES THE PATIENT HAS HAEMOPTYSIS FOLLOWED BY PROTRACTED CARDIAC ARREST AND IS TRANSFERRED EMERGENTLY TO CARDIOTHORACIC THEATRES WHERE A SALVAGE PNEUMONECTOMY WAS PERFORMED. THE PATHOLOGIST CONFIRMS IATROGENIC RUPTURE OF THE PULMONARY ARTERY. IT WAS CONFIRMED THAT THE INTERNAL CARDIOVERSION SHOCK WAS NOT DELIVERED. WITHDRAWAL OF TREATMENT AFTER 8 DAYS DUE TO A NON-RECOVERABLE HYPOXIC BRAIN INJURY, PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298158 ALERT INTERNAL CARDIOVERSION CATHETER SYSTEM,PACING,TEMPORARY,ACUTE,INTERNAL ATRIAL DEFIBRILLATION MTE DOT MEDICAL PRODUCTS LTD AL-SP75149

    Patients

    Seq Age Sex Outcome Treatment
    1 Death INITIAL ABLATION DEVICE| WHISPER GUIDE WIRE¿