BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN® ACCESS SYSTEM

    MDR report key: 6526120 · Received April 27, 2017

    Report

    Report Number
    2134265-2017-03906
    Event Type
    Injury
    Date Received
    April 27, 2017
    Date of Event
    April 4, 2017
    Report Date
    April 4, 2017
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NGV
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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).

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM, PATIENT CODES, CATALOG/MODEL #, DEVICE LOT NUMBER, DEVICE MANUFACTURED DATE, MFG SITE NAME: UPDATED MANUFACTURER NAME UPDATED FROM BOSTON SCIENTIFIC - (B)(4) TO BOSTON SCIENTIFIC - (B)(4). UPN- SEARCH UPDATED FROM UNK728 - WATCHMAN ACCESS SYSTEM - CMC - MAPLE GROVE (INTERVENT CARDIO) - 60000 TO M635TU20060 - FG WATCHMAN ACCESS SYS DOUBLE CURVE, US - TU2006 UPN UPDATED FROM UNK728 TO M635TU20060. PMA# OR 510K# UPDATED FROM M110009 TO P130013. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR: 2134265-2017-03905. IT WAS REPORTED THAT A PERICARDIAL EFFUSION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A 33MM WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM AND A WATCHMAN ® ACCESS SYSTEM WERE ELECTED. HOWEVER, DURING THE PROCEDURE A PERICARDIAL EFFUSION OCCURRED WHICH REQUIRED SURGICAL REPAIR. THEY WERE UNABLE TO COMPLETE THE LAA PROCEDURE AND THE PATIENT CURRENT STATUS IS OK.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE WAS WAS DEEP SEATED IN THE LAA. A PERFORATION WITH CARDIAC TAMPONADE OCCURRED DURING DEPLOYMENT OF THE DEVICE. THE WAS AND WDS WERE ADVANCED TOO FAR DISTALLY. SWEEPS WERE PERFORMED CONSISTENTLY THROUGHOUT THE PROCEDURE. THE CLOSURE DEVICE WAS RELEASED AS IT WAS DETERMINED THAT WAS THE SAFEST COURSE OF ACTION. RECAPTURING THE DEVICE WOULD HAVE CAUSED A LARGER HOLE IN THE APPENDAGE. THE CLOSURE DEVICE WAS EVENTUALLY REMOVED AND THE LAA WAS SURGICALLY CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306437 WATCHMAN® ACCESS SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC - GALWAY M635TU20060 19994994

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention