BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KITS

    MDR report key: 2110061 · Received June 1, 2011

    Report

    Report Number
    3005099803-2011-01858
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K071957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE CAPIO DEVICE WAS NOT RECEIVED FOR ANALYSIS. VISUAL ANALYSIS OF THE RETURNED MESH ASSEMBLY REVEALED THAT THE NEEDLE WAS MISSING FROM THE BLUE AND WHITE DILATOR. THE NEEDLE WAS NOT RETURNED. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT SHOWED NO EVIDENCE OF A MANUFACTURING-RELATED POTENTIAL CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING PREPARATION OF AN ANTERIOR REPAIR PROCEDURE USING A PINNACLE ANTERIOR/APICAL PELVIC FLOOR REPAIR KIT, AS THE FIRST LEG ASSEMBLY WAS BEING LOADED INTO THE CAPIO DEVICE, THE SUTURE (WITH THE NEEDLE AT THE END) DETACHED, OUTSIDE OF THE PATIENT. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER PINNACLE ANTERIOR/APICAL PELVIC FLOOR REPAIR KIT WITH NO COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING PREPARATION OF AN ANTERIOR REPAIR PROCEDURE USING A PINNACLE ANTERIOR/APICAL PELVIC FLOOR REPAIR KIT, AS THE FIRST LEG ASSEMBLY WAS BEING LOADED INTO THE CAPIO DEVICE, THE SUTURE (WITH THE NEEDLE AT THE END) DETACHED, OUTSIDE OF THE PATIENT. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER PINNACLE ANTERIOR/APICAL PELVIC FLOOR REPAIR KIT WITH NO COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE PELVIC FLOOR REPAIR KITS MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317050 1ML0052701

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR