BEUDAMED
    FDA Adverse Event Death Summary report: N

    PACEL BIPOLAR PACING CATHETER

    MDR report key: 20707527 · Received November 18, 2024

    Report

    Report Number
    2182269-2024-00041
    Event Type
    Death
    Date Received
    November 18, 2024
    Date of Event
    November 14, 2024
    Report Date
    December 18, 2024
    Manufacturer
    ST. JUDE MEDICAL HEA
    Product Code
    LDF
    UDI-DI
    05414734001137
    PMA / PMN Number
    K152784
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED CARDIAC PERFORATION AND SUBSEQUENT DEATH REMAINS UNKNOWN. PER THE IFU, CARDIAC PERFORATION IS A KNOWN RISK DURING THE USE OF THIS DEVICE.

    Description of Event or Problem · 0

    DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE, A CARDIAC PERFORATION OCCURRED LEADING TO THE PATIENT EXPIRING ONE DAY POST PROCEDURE. ON (B)(6) 2024, A TEMPORARY PACEMAKER WAS IMPLANTED DURING THE VALVE IMPLANT PROCEDURE AND CONNECTED TO AN EXTERNAL PACEMAKER GENERATOR, CONFIRMING CORRECT OPERATION. THE PATIENT WAS THEN TRANSFERRED TO THE ICU. THE FOLLOWING DAY, THE PATIENT EXPERIENCED HEMODYNAMIC DECOMPENSATION AND WAS DIAGNOSED WITH CARDIAC TAMPONADE SECONDARY TO A PERFORATION AT THE SITE OF THE PACEL. THE PATIENT WAS TRANSFERRED TO SURGERY FOR A PERICARDIAL WINDOW PROCEDURE, HOWEVER, THE PATIENT EXPIRED.

    Description of Event or Problem · 0

    DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE, A CARDIAC PERFORATION OCCURRED, AND THE PATIENT EXPIRED ONE DAY POST PROCEDURE. ON (B)(6) 2024, A PACEL CATHETER WAS PLACED DURING THE VALVE IMPLANT PROCEDURE AND CONNECTED TO AN EXTERNAL PACEMAKER GENERATOR. THE CATHETER WAS PLACED WITHOUT ANY DIFFICULTY. FOLLOWING THE PROCEDURE, THE PATIENT WAS TRANSFERRED TO THE ICU. THE FOLLOWING DAY, THE PATIENT EXPERIENCED HEMODYNAMIC DECOMPENSATION AND WAS DIAGNOSED WITH CARDIAC TAMPONADE SECONDARY TO A PERFORATION AT THE SITE OF THE PACEL (ANTERIOR SURFACE OF THE RIGHT VENTRICLE). THE PATIENT WAS TRANSFERRED TO SURGERY FOR A PERICARDIAL WINDOW PROCEDURE, HOWEVER THE PATIENT EXPIRED. THERE WERE NO PRODUCT PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2609618 PACEL BIPOLAR PACING CATHETER ELECTRODE, PACEMAKER, TEMPORARY LDF ST. JUDE MEDICAL HEA 401771 8858013 05414734001137

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death