BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KIT

    MDR report key: 1230038 · Received November 12, 2008

    Report

    Report Number
    3005099803-2008-06414
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 13, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FTM
    PMA / PMN Number
    K071957
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A DEVICE HISTORY REVIEW SHOWS NO EVIDENCE OF A MANUFACTURING-RELATED POTENTIAL CAUSE FOR THIS EVENT. A REVIEW OF THE LABELING SHOWS THAT THE DEVICE WAS USED ACCORDINGLY FOR TISSUE REINFORCEMENT AND STABILIZATION OF FASCIAL STRUCTURES OF THE PELVIC FLOOR. THE INVESTIGATION CONCLUDED THAT THE EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    A PINNACLE PELVIC FLOOR REPAIR KIT WAS USED DURING AN ANTERIOR FLOOR REPAIR PROCEDURE IN 2008, (PT AGE AND WEIGHT ARE UNK). ACCORDING TO THE COMPLAINANT, THE PT PRESENTED WITH A LARGE ANTERIOR DEFECT. THE PINNACLE DEVICE WAS IMPLANTED SUCCESSFULLY BOTH ANTERIOR AND POSTERIOR. THE POSTERIOR INCISION WAS CLOSED AND AN ADVANTAGE FIXED SLING WAS IMPLANTED. A CYSTOSCOPY WAS PERFORMED AND A PERFORATION WAS VISUALIZED IN THE BLADDER, WHICH WAS NOT ATTRIBUTED TO THE ADVANTAGE SLING. ONE OF THE ATTENDING PHYSICIANS OPINED THAT THE PERFORATION WAS DUE TO THE DISSECTION, AND NOT TO THE PINNACLE DEVICE. THROUGH THE HOLE, POSTERIORLY, PINNACLE MESH WAS VISIBLE. IT APPEARED THAT THE PT'S RIGHT URETER HAD BEEN PERFORATED AND THERE WAS BLACK CAUTERY AROUND THE HOLE IN THE BLADDER. THE UROLOGIST WAS CALLED IN AND ALL ATTENDING PHYSICIANS FELT IT WOULD BE BEST FOR THE PT TO REMOVE THE PINNACLE, SO IT WAS REMOVED. THE PT'S CONDITION IS REPORTED AS "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE PELVIC FLOOR REPAIR KIT FTM BOSTON SCIENTIFIC CORPORATION M0068317050 OML8071402

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention