BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHMAN® ACCESS SYSTEM

    MDR report key: 5061723 · Received September 8, 2015

    Report

    Report Number
    2134265-2015-05860
    Event Type
    Death
    Date Received
    September 8, 2015
    Date of Event
    August 10, 2015
    Report Date
    August 10, 2015
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NGV
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT WHEN THE WAS MOVED FORWARD WHILE ADVANCING THE WDS, A PERFORATION OF THE LAA OCCURRED. THE PATIENT ALSO EXPERIENCED TAMPONADE.

    Description of Event or Problem · 1

    SAME CASE AS MFR ID: 2134265-2015-05859. IT WAS REPORTED THAT PERICARDIAL EFFUSION AND DEATH OCCURRED. THE PATIENT WAS UNDERGOING A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE. A WATCHMAN® ACCESS SYSTEM (WAS) WAS ADVANCED OVER A PIGTAIL CATHETER AND ALIGNED TO THE OSTIUM OF THE LAA. THERE WAS STILL DEPTH DISTAL TO THE WAS. THE PIG TAIL CATHETER WAS REMOVED AND A 24MM WATCHMAN ® LAA CLOSURE DEVICE AND DELIVERY SYSTEM (WDS) WAS THEN INTRODUCED INTO THE WAS. WHILE ADVANCING THE WDS, PRIOR TO REACHING THE DISTAL END OF THE WAS, THE WAS MOVED FORWARD. CONTRAST WAS INJECTED AND THE WAS WAS VISIBLE IN THE PERICARDIAL SPACE. THE SYSTEM WAS REMOVED FROM THE PERICARDIAL SPACE AND THE PATIENT'S CHEST WAS PREPPED. PERICARDIOCENTESIS WAS PERFORMED. THE DRAINED BLOOD WAS REINFUSED AND CLOTS WERE VISIBLE IN THE LEFT VENTRICLE. PROTAMINE WAS ADMINISTERED AS WELL AS DRUGS TO TREAT THE DROP IN BLOOD PRESSURE. THE PATIENT STARTED CRASHING. CHEST COMPRESSIONS WERE PERFORMED; HOWEVER, THE PATIENT ULTIMATELY EXPIRED ON THE TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593428 WATCHMAN® ACCESS SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC - MAPLE GROVE M635TU20060 18097804

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death| R