BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN® ACCESS SYSTEM

    MDR report key: 6109018 · Received November 17, 2016

    Report

    Report Number
    2134265-2016-11008
    Event Type
    Injury
    Date Received
    November 17, 2016
    Date of Event
    October 19, 2016
    Report Date
    October 19, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NGV
    UDI-DI
    08714729838197
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    SAME CASE AS MDR ID: 2134265-2016-10135, 2134265-2016-11007 AND 2134265-2016-11009. IT WAS REPORTED A PERICARDIAL EFFUSION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. PRIOR TO THE PROCEDURE, A BASELINE PERICARDIAL EFFUSION WAS NOTICED. A DOUBLE CURVE WATCHMAN ACCESS SYSTEM (WAS) WAS USED, BUT NO WATCHMAN LAA CLOSURE DEVICE AND DELIVERY SYSTEM (WDS) WAS ADVANCED THROUGH THE ACCESS SYSTEM. THEY EXCHANGED THE ACCESS SYSTEM FOR A SINGLE CURVE WATCHMAN ACCESS SYSTEM. IT WAS ADVANCED WITH THE PIGTAIL IN PLACE WITHIN THE LAA. THE PHYSICIAN HAD A LOT OF TORQUE ON THE ACCESS SYSTEM DUE TO THE SMALL PATIENT ANATOMY AND CURVATURE OF THE LAA AND THE ACCESS SYSTEM APPEARED TO DO A 180 DEGREE TURN IN THE LAA. AN IMMEDIATE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SWEEP WAS PERFORMED WHICH REVEALED NO CHANGE IN THE BASELINE EFFUSION. THEY REMOVED THE ACCESS SYSTEM AND EXCHANGED IT FOR AN ANTERIOR CURVE WATCHMAN ACCESS SYSTEM AND INSERTED A 21MM WDS. THIS CLOSURE DEVICE WAS DEPLOYED, BUT WAS TOO PROXIMAL, SO IT WAS FULLY RECAPTURED AND REMOVED. ABOUT 10 MINUTES LATER, WHEN THEY WERE PREPARING ANOTHER 21MM WDS, THEY NOTICED A SMALL AMOUNT OF FLUID ACCUMULATING AROUND THE LEFT ATRIUM. THE EFFUSION INCREASED A LITTLE AND EXPANDED INTO THE LEFT VENTRICLE. IT WAS DETERMINED THE EFFUSION WAS STABLE AND THEY PROCEEDED WITH THE PROCEDURE. THE PATIENT WAS HEMODYNAMICALLY STABLE AND THEIR ACTIVATED CLOTTING TIME (ACT) WAS 242. NO INTERVENTION WAS NECESSARY. THE 21 MM WDS WAS INSERTED AND THE CLOSURE DEVICE WAS SUCCESSFULLY DEPLOYED. AS A PRECAUTION, THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT AND THE HEPARIN WAS REVERSED WITH PROTAMINE AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762016 WATCHMAN® ACCESS SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC - MAPLE GROVE M635TU10060 18342580 08714729838197

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other