BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 16755842 · Received April 17, 2023

    Report

    Report Number
    2124215-2023-17075
    Event Type
    Injury
    Date Received
    April 17, 2023
    Date of Event
    April 9, 2023
    Report Date
    July 11, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT - AWARE DATE OF (B)(6) 2023 USED AS EVENT DATE IS UNKNOWN. H6: IMPACT CODES - UPDATED F1001 ABSENCE OF TREATMENT TO F2303 MEDICATION REQUIRED.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT - AWARE DATE OF (B)(6) 2023 USED AS EVENT DATE IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA SOCIAL MEDIA THAT BLOOD LOSS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS ATTEMPTED USING A WATCHMAN FLX LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS). DURING THE PROCEDURE, A HEMORRHAGE OCCURRED AND THE PROCEDURE WAS ABORTED. THE PATIENT RECOVERED AND WAS PLACED ON ANTICOAGULANT MEDICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA SOCIAL MEDIA THAT A HEMORRHAGE OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS ATTEMPTED USING A WATCHMAN FLX LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS). DURING THE PROCEDURE, A HEMORRHAGE OCCURRED AND THE PROCEDURE WAS ABORTED. THE PATIENT RECOVERED AND WAS PLACED ON ANTICOAGULANT MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1808258 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other