BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIO CL TRANSVAGINAL SUTURE CAPTURING DEVICE

    MDR report key: 1333372 · Received March 5, 2009

    Report

    Report Number
    3005099803-2008-01878
    Event Type
    Injury
    Date Received
    March 5, 2009
    Date of Event
    August 3, 2005
    Report Date
    August 4, 2005
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION-MIAMI
    Product Code
    FHQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT SHOWS NO EVIDENCE OF A MANUFACTURING-RELATED POTENTIAL CAUSE FOR THIS EVENT. 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 OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A PROCEDURE USING A CAPIO CL SUTURE CAPTURING DEVICE, THE DEVICE MISFIRED TWICE, LEAVING TWO NEEDLES INSIDE THE PATIENT. THE PHYSICIAN DECIDED THEY WERE TOO SMALL TO RETRIEVE. THE PATIENT WAS REPORTEDLY "FINE" POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIO CL TRANSVAGINAL SUTURE CAPTURING DEVICE HOLDER, NEEDLE, GASTROENTEROLOGIC FHQ BOSTON SCIENTIFIC CORPORATION-MIAMI M0068311350 6961068

    Patients

    Seq Age Sex Outcome Treatment
    1 Other