BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC CAPIO SLIM

    MDR report key: 15242607 · Received August 16, 2022

    Report

    Report Number
    MW5111533
    Event Type
    Injury
    Date Received
    August 16, 2022
    Date of Event
    August 2, 2022
    Report Date
    August 15, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PWI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC CAPIO SLIM SUTURE PASSER DEVICE (M0068318250 / LOT 29270438) OPENED FOR PROCEDURE AND LOADED WITH SUTURE (833-124). DR ATTEMPTED TO USE DEVICE AS NORMAL BUT IT FAILED TO PROPERLY PASS THE SUTURE. HE REATTEMPTED TO PASS THE SUTURE, BUT THE BULLET NEEDLE OF THE SUTURE BROKE OFF. THE DEVICE WAS PARTLY DISASSEMBLED TO TRY TO LOCATE THE NEEDLE, RENDERING IT NONFUNCTIONAL. THE OPERATIVE SITE WAS ALSO THOROUGHLY INSPECTED. ALTHOUGH THE NEEDLE WAS NOT LOCATED, THE SURGEON DID LOCATE AN UNIDENTIFIED, ROUND, PLASTIC PELLET APPROXIMATELY 1.5-2 MM IN DIAMETER IN THE OPERATIVE SITE. IT DID NOT APPEAR TO HAVE COME FROM THE SUTURE PASSER AS IT WAS TOO LARGE TO FIT ANYWHERE IN THE DEVICE TIP, AND WAS KEPT AS AN UNKNOWN FOREIGN BODY. A REPLACEMENT DEVICE WAS UNAVAILABLE SO THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE TECHNIQUE. RADIOLOGY WAS NOTIFIED TO COME DO AN X-RAY FOR A MISSING NEEDLE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1848236 BOSTON SCIENTIFIC CAPIO SLIM INSTRUMENTATION, SURGICAL MESH, UROGYNECOLOGIC, TRANSVAGINAL REPAIR OF PELVIC OR PWI BOSTON SCIENTIFIC CORPORATION M0068318250 29270438

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention