BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KIT

    MDR report key: 1260085 · Received December 10, 2008

    Report

    Report Number
    3005099803-2008-07048
    Event Type
    Injury
    Date Received
    December 10, 2008
    Date of Event
    November 11, 2008
    Report Date
    November 11, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FTM
    PMA / PMN Number
    K071957
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS IMPLANTED 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 CORPORATION THAT DURING AN ANTERIOR PELVIC FLOOR REPAIR PROCEDURE USING A PINNACLE PFR KIT, THE BULLET DETACHED FROM THE SUTURE INSIDE THE PATIENT AND WAS NOT RETRIEVED. AN X-RAY SHOWED THE BULLET BURIED IN THE LEFT ARCUATE LIGAMENT. THE PHYSICIAN GOT ANOTHER CAPIO SUTURE, ATTACHED IT TO THE DILATOR TUBE, AND THEN PULLED IT THROUGH THE ARCUS TENDINEOUS TO COMPLETE THE PROCEDURE. THE PATIENT'S CONDITION IS REPORTEDLY "FINE" POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE PELVIC FLOOR REPAIR KIT FTM BOSTON SCIENTIFIC CORPORATION M0068317050 0ML8063004

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other