BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE FLOOR REPAIR KIT

    MDR report key: 1101728 · Received August 7, 2008

    Report

    Report Number
    3005099803-2008-01530
    Event Type
    Injury
    Date Received
    August 7, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FTM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED, AND WILL NOT BE RETURNED FOR EVAL; 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 THAT DURING AN ANTERIOR PELVIC FLOOR REPAIR PROCEDURE, USING THE PINNACLE PFR KIT, THE DILATOR OF THE MESH LEG BUNCHED UP AND WOULD NOT PASS THROUGH THE ARCUS TENDINOUS, CAUSING THE SUTURE TO SNAP. THE NEEDLE WAS RETRIEVED. THE PHYSICIAN ATTACHED ANOTHER SUTURE TO THE MESH LEG AND TIED THE GRAFT INTO PLACE. A CYSTOSCOPY THEN REVEALED THERE WAS NO FLOW THROUGH ONE OF THE PATIENT'S URETERS. THE PHYSICIAN REMOVED THE SUTURE HE HAD USED TO REPLACE THE SNAPPED ONE, AND FLOW RESUMED. A UROLOGIST THEN PERFORMED AN INTRAVENOUS PYELOGRAM, WHICH SHOWED AN EXTRAVASATION OF URINE. THE GRAFT WAS REMOVED, AND A FLUOROSCOPY WAS PERFORMED REVEALING A KINK IN THE URETER, WHICH THE PHYSICIAN OPINED MAY BE A PRE-EXISTING DEFECT. THE PT IS REPORTEDLY "FINE" POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE FLOOR REPAIR KIT FTM BOSTON SCIENTIFIC CORPORATION M0068317050 0ML8050701

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention