BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHMAN TRUSTEER ACCESS SYSTEM

    MDR report key: 21505431 · Received March 3, 2025

    Report

    Report Number
    2124215-2025-09219
    Event Type
    Death
    Date Received
    March 3, 2025
    Date of Event
    February 13, 2025
    Report Date
    March 3, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQY
    UDI-DI
    00191506022310
    PMA / PMN Number
    K240018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF DEATH IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ST ELEVATION, BRAIN INJURY, AND DEATH OCCURRED. A CONCOMITANT PROCEDURE WAS BEING PERFORMED WITH INTRACARDIAC ECHOCARDIOGRAM (ICE) IMAGING UNDER DEEP SEDATION WITH NO INTUBATION PERFORMED. A PULSE FIELD ABLATION (PFA) PROCEDURE WAS PERFORMED SUCCESSFULLY FIRST USING FARAPULSE PFA SYSTEM. SOMETIME BETWEEN THE CAVOTRICUSPID ISTHMUS LINE (CTI) LINE ABLATION PORTION AND THE INSERTION OF THE WATCHMAN TRUSTEER ACCESS SYSTEM (WAS) FOR THE INITIATION OF THE LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE, THE PATIENT HAD SUDDEN ST ELEVATION AND HYPOTENSION. AIR WAS SUSPECTED, SO NITRO MEDICATION WAS ADMINISTERED VIA INTRACARDIAC DELIVERY. A 31 MM WATCHMAN FLX PRO DELIVERY SYSTEM AND CLOSURE DEVICE (WDS) WAS QUICKLY INSERTED THROUGH THE WAS AND DEPLOYED SUCCESSFULLY, JUST IN CASE AIR WAS PRESENT IN THE DISTAL LAA. THE INTERVENTIONAL CARDIOLOGIST PERFORMED A DIAGNOSTIC INTERVENTION TO LOOK FOR PRESENT AIR IN THE CORONARY ARTERIES, BUT NO AIR WAS EVER VISUALIZED IN THE PATIENT. THE ST ELEVATIONS SELF-RESOLVED AND THE PATIENT REGAINED NORMAL HEMODYNAMICS. THE PROCEDURE WAS CONCLUDED. THE PATIENT WAS HOSPITALIZED YET NEVER REGAINED CONSCIOUSNESS POST INDEX PROCEDURE. MAGNETIC RESONANCE IMAGING (MRI) SCAN AND MULTIPLE COMPUTED TOMOGRAPHY (CT) SCANS WERE PERFORMED AND REVEALED NO AREA OF CONCERN, AND NO AIR WAS FOUND. HOSPICE CARE WAS INITIATED AND THE PATIENT DIED SEVERAL DAYS POST INDEX PROCEDURE ON AN UNKNOWN DATE. THE OFFICIAL CAUSE OF DEATH IS ANOXIC BRAIN INJURY DUE TO GLOBAL HYPOXIA. THE PHYSICIAN STATED THE DEATH HAD NO OFFICIAL RELATIONSHIP TO THE DEVICES USED OR THE PROCEDURE ITSELF AND IT WAS UNKNOWN WHAT CAUSED THE ANOXIC BRAIN INJURY OTHER THAN IT WAS POSSIBLE THE NON-INTUBATED PATIENT HAD TAKEN A DEEP BREATH WHILE THE WAS WAS IN THE GROIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1345265 WATCHMAN TRUSTEER ACCESS SYSTEM CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC CORPORATION M635TU90050 0035304828 00191506022310

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Death