BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE

    MDR report key: 1082270 · Received July 24, 2008

    Report

    Report Number
    3005099803-2008-01277
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    April 29, 2008
    Report Date
    June 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MFJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS RETAINED 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 FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT DURING A VAGINAL VAULT SACROSPINOUS LIGAMENT FIXATION PROCEDURE USING THE CAPIO SUTURING DEVICE, AND A TELEFLEX POLYPROPYLENE SUTURE (NON-BSC PRODUCT), THE BULLET DETACHED INSIDE THE PT. THE PHYSICIAN WAS UNABLE TO FIND OR RETRIEVE THE BULLET. THE PT 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 11346463

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other TELEFLEX POLYPROPYLENE SUTURE (NON-BSC PRODUCT)