BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE

    MDR report key: 1311585 · Received February 10, 2009

    Report

    Report Number
    3005099803-2009-00481
    Event Type
    Injury
    Date Received
    February 10, 2009
    Date of Event
    September 28, 2008
    Report Date
    January 13, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND 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 OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT DURING A TRANSVAGINAL SLING PROCEDURE USING A CAPIO SUTURING DEVICE, THE SUTURE BULLET DISLODGED AND WAS NOT RETRIEVABLE. X-RAYS OF THE PT DID NOT REVEAL THE BULLET, BUT IT IS ASSUMED TO BE INSIDE THE PT. THE PT REPORTEDLY SUFFERED NO OTHER COMPLICATIONS AS A RESULT OF THIS EVENT, AND WAS "FINE" POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE FHQ BOSTON SCIENTIFIC CORPORATION M0068311251 11924472

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other