BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KITS

    MDR report key: 2151983 · Received July 7, 2011

    Report

    Report Number
    3005099803-2011-02172
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 13, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K071957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPONENT (B)(4) RELATES TO DEVICE (B)(4) FOR NEEDLE DETACHMENT.

    Additional Manufacturer Narrative · 1

    VISUAL ANALYSIS OF THE RETURNED MESH ASSEMBLY REVEALED THAT THE NEEDLE WAS MISSING FROM THE SOLID BLUE DILATOR. THE NEEDLE WAS NOT RETURNED. VISUAL ANALYSIS OF THE RETURNED CAPIO DEVICE REVEALED NO DEFECTS. FUNCTIONAL TESTING OF THE RETURNED CAPIO DEVICE SHOWED THAT THE DEVICE OPERATED PROPERLY AS INTENDED. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT SHOWED NO EVIDENCE OF A MANUFACTURING-RELATED POTENTIAL CAUSE FOR THIS EVENT. THE CAUSE FOR THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A POSTERIOR PELVIC FLOOR REPAIR PROCEDURE USING A PINNACLE POSTERIOR PELVIC FLOOR REPAIR KIT, AS A LEG ASSEMBLY WAS BEING THROWN THROUGH TISSUE, THE NEEDLE DETACHED AND WAS REPORTEDLY CAPTURED INSIDE THE CAPIO CAGE. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER PINNACLE POSTERIOR PELVIC FLOOR REPAIR KIT WITH NO COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY GREAT AND IS OVER 18 YEARS OF AGE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A POSTERIOR PELVIC FLOOR REPAIR PROCEDURE USING A PINNACLE POSTERIOR PELVIC FLOOR REPAIR KIT, AS A LEG ASSEMBLY WAS BEING THROWN THROUGH TISSUE, THE NEEDLE DETACHED AND WAS REPORTEDLY CAPTURED INSIDE THE CAPIO CAGE. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER PINNACLE POSTERIOR PELVIC FLOOR REPAIR KIT WITH NO COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY GREAT AND IS OVER 18 YEARS OF AGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE PELVIC FLOOR REPAIR KITS MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317100 ML00000064

    Patients

    Seq Age Sex Outcome Treatment
    1