BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE

    MDR report key: 1081573 · Received July 25, 2008

    Report

    Report Number
    3005099803-2008-01306
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 23, 2008
    Report Date
    June 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MFJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT AGE UNK. THE DEVICE HAS NOT BEEN RECEIVED BY THIS MANUFACTURER. AN EVAL HAS NOT BEEN PERFORMED; 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 (BSC) THAT DURING A VAGINAL VAULT REPAIR PROCEDURE USING THE CAPIO SUTURING DEVICE, AFTER THE SUTURE WAS PASSED THROUGH THE SACROSPINOUS LIGAMENT, THE CAPIO DEVICE "CUT" THROUGH THE TELEFLEX POLYPROPYLENE SUTURE (NON-BSC PRODUCT), DETACHING THE BULLET. THE BULLET WAS NOT LOST INSIDE THE PT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO COMPLICATIONS TO THE PT WHO IS REPORTEDLY "STABLE" 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 11724619

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK TELEFLEX POLYPROPYLENE SUTURE (NON-BSC PRODUCT)