BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE

    MDR report key: 1314338 · Received February 17, 2009

    Report

    Report Number
    3005099803-2009-00603
    Event Type
    Injury
    Date Received
    February 17, 2009
    Date of Event
    December 23, 2008
    Report Date
    January 20, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE DEVICE IS UNKNOWN; CONSEQUENTLY, THE MANUFACTURE 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 OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING AN ANTERIOR PELVIC FLOOR REPAIR PROCEDURE USING A CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE AND A GORTEX SUTURE TO PLACE A REPLIFORM GRAFT, THE BULLET DETACHED TO THE OBTURATOR INTERNUS MUSCLE IN THE PELVIC SIDE WALL. THE PHYSICIAN DETERMINED THAT THE MORBIDITY OF ATTEMPTING TO RETRIEVE THE BULLET WOULD OUTWEIGH THE BENEFIT OF RETRIEVING THE BULLET, SO THE BULLET WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS CAPIO DEVICE WITH NO FURTHER COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY "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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other REPLIFORM GRAFT (A LIFECELL PRODUCT DISTRIBUTED BY| GORTEX SUTURE (NOT A BOSTON SCIENTIFIC PRODUCT)| BOSTON SCIENTIFC)