BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WATCHMAN ACCESS SYSTEM

    MDR report key: 19082391 · Received April 10, 2024

    Report

    Report Number
    2124215-2024-20321
    Event Type
    Malfunction
    Date Received
    April 10, 2024
    Date of Event
    March 24, 2020
    Report Date
    April 10, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ESTIMATED AS 03/24/2020 AS THE PUBLISHED DATE FOR THE ARTICLE IS NOTED AS MARCH 24, 2020. LITERATURE CITATION: DIMTRI, F, KHAN, K, VARGAS, C. ET AL. (2020) A KINK IN THE SYSTEM: ENCOUNTERING AND CORRECTING A WATCHMAN PERIPROCEDURAL COMPLICATION. J AM COLL CARDIOL. 75 (11_SUPPLEMENT_1) 3224. HTTPS://DOI.ORG/10.1016/S0735-1097(20)33851-1.

    Description of Event or Problem · 0

    REPORTED VIA JOURNAL ARTICLE IT WAS REPORTED THAT A SHEATH KINK OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) AND A 27MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED TO BE USED. DURING THE PROCEDURE, TRANS-SEPTAL ACCESS WITH A DOUBLE-CURVED WAS WAS UTILIZED BASED ON TRANSESOPHAGEAL ECHOCARDIOGRAM. A 27 MM WATCHMAN CLOSURE DEVICE WAS THEN DEPLOYED. HOWEVER, THE DEVICE DISLODGED DURING THE TUG-TEST. RECAPTURE OF THE WATCHMAN CLOSURE DEVICE REVEALED A SHARP BEND IN THE WAS AT THE LEVEL OF THE SEPTAL PUNCTURE. REPEATED MANIPULATION OF THE WAS AND THE WATCHMAN CLOSURE DEVICE FAILED TO RELIEVE THE KINK. THE WATCHMAN CLOSURE DEVICE WAS UNRETRIEVABLE WITHIN THE LEFT ATRIAL (LA) CAVITY. THE PHYSICIAN OPTED TO TRY TO RELIEVE THE KINK BY INTRODUCING A NON-BOSTON SCIENTIFIC (BSC) AMPLATZ SUPER STIFF WIRE THROUGH THE 14 FR DELIVERY SHEATH. THE KINKED REGION WAS THEN STRAIGHTENED OUT ALLOWING THE WATCHMAN CLOSURE DEVICE TO BE FULLY RETRACTED AND REMOVED. USING AN ANTERIOR CURVE SHEATH, A NEW WATCHMAN CLOSURE DEVICE WAS SUCCESSFULLY DEPLOYED IN A STABLE POSITION IN THE LAA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023098 WATCHMAN ACCESS SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male