BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN® ACCESS SYSTEM

    MDR report key: 6041308 · Received October 19, 2016

    Report

    Report Number
    2134265-2016-09693
    Event Type
    Injury
    Date Received
    October 19, 2016
    Date of Event
    September 20, 2016
    Report Date
    September 20, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NGV
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE WATCHMAN ® LAA CLOSURE DEVICE WAS A 30MM DEVICE, NOT A 24MM DEVICE.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2016-09194. IT WAS REPORTED A PERFORATION WITH PERICARDIAL EFFUSION AND TAMPONADE OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A 24MM WATCHMAN ® LAA CLOSURE DEVICE AND DELIVERY SYSTEM (WDS) WAS ADVANCED THROUGH A WATCHMAN ® ACCESS SYSTEM (WAS). WHEN THE PHYSICIAN WAS PULLING THE WAS BACK TO DEPLOY THE CLOSURE DEVICE, THE PATIENT SUDDENLY BENT HIS LEGS. RADIOGRAPHY WAS PERFORMED AND IT WAS NOTICED THAT THE CONTRAST FLOWED INTO THE PERICARDIUM; PERICARDIAL EFFUSION OCCURRED. THE CLOSURE DEVICE WAS RELEASED AFTER A SHORT REVIEW TO CONFIRM ALL RELEASE CRITERIA WERE MET. THEY THEN PERFORMED A PERICARDIAL PUNCTURE WHERE A TOTAL OF 800ML OF BLOOD WAS WITHDRAWN AND REINFUSED INTRAVENOUSLY. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) HAD MEASURED THE PERICARDIAL EFFUSION AT 14MM. THE PATIENT WAS STABLE UNTIL ENTERING A HYPOTONIC PHASE (30/10 MMHG); CARDIAC TAMPONADE OCCURRED. PROTAMINE WAS ADMINISTERED TO REVERSE THE 5000 I.U. OF HEPARIN ADMINISTERED DURING THE INTERVENTION. THE SUBSEQUENT ACTIVATED CLOTTING TIME (ACT) GAVE A VALUE OF 150, SO ANOTHER 2,500 I.U. OF PROTAMINE WAS ADMINISTERED. ABOUT 15 MINUTES LATER THE ACT REACHED 120. ABOUT ONE HOUR AFTER THE COMPLICATION OCCURRED, THE PERICARDIAL EFFUSION HAD DECREASED TO 3MM AND NO ADDITIONAL BLOOD COULD BE DRAINED. DURING THE NEXT 6 HOURS OF OBSERVATION FOLLOWING THE EVENT, THE PATIENT WAS SYMPTOM FREE AND STABLE. A NEW TRANSTHORACIC ECHOCARDIOGRAM (TTE) EXAMINATION SHOWED NO FURTHER INCREASE IN THE PERICARDIAL EFFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693127 WATCHMAN® ACCESS SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC - MAPLE GROVE M635TS20060

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention