BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE

    MDR report key: 1150480 · Received September 5, 2008

    Report

    Report Number
    3005099803-2008-04413
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MFJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE DEVICE IS UNK; THEREFORE, THE MFR AND EXPIRATION DATES CANNOT BE DETERMINED. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT DURING A CYSTOCELE REPAIR PROCEDURE USING A CAPIO SUTURE CAPTURING DEVICE, THE BULLET DETACHED FROM THE SUTURE INSIDE THE PT'S ARCUS TENDINEOUS. WHILE ATTEMPTING TO RETRIEVE THE BULLET, THE PHYSICIAN INADVERTENTLY PERFORATED THE PT'S BLADDER. HE WAS UNSUCCESSFUL IN RETRIEVING THE BULLET. THE PHYSICIAN AND A UROLOGIST REPAIRED THE BLADDER. AFTER THE PROCEDURE, AN X-RAY REVEALED A SMALL SPOT IN THE SAME LOCATION THE BULLET WAS LOST. THE PT'S CONDITION IS REPORTED AS "FINE" POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE MFJ BOSTON SCIENTIFIC CORPORATION M0068311251 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention TELEFLEX POLYPROPYLENE SUTURE