BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KITS

    MDR report key: 2071140 · Received April 27, 2011

    Report

    Report Number
    3005099803-2011-01364
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K071957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A POSTERIOR REPAIR PROCEDURE USING A PINNACLE POSTERIOR PELVIC FLOOR REPAIR KIT, AS THE FIRST MESH LEG ASSEMBLY WAS BEING THROWN THROUGH TISSUE, A BIT OF THE SUTURE (WITH THE NEEDLE AT THE END) DETACHED. THE SUTURE AND NEEDLE WERE 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 "FINE" POST-PROCEDURE.

    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 1ML0122101

    Patients

    Seq Age Sex Outcome Treatment
    1