BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KITS

    MDR report key: 3020024 · Received March 25, 2013

    Report

    Report Number
    3005099803-2013-01905
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K071957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN. VISUAL ANALYSIS OF THE RETURNED CAPIO DEVICE REVEALED THAT THE HANDLE WAS CRACKED; THIS LIKELY OCCURRED DURING THE RETURN SHIPMENT. VISUAL ANALYSIS OF THE RETURNED MESH ASSEMBLY REVEALED THAT THE LEAD SUTURE ON THE BLUE DILATOR WAS BROKEN, WITH ITS END FRAYED. THE NEEDLE WAS MISSING AND WAS NOT RETURNED. IN ADDITION, A SMALL PORTION OF THE DILATOR WAS PEELED FROM THE LEAD SUTURE. SINCE THE EVENT OCCURRED OUTSIDE THE PATIENT WHILE THE NEEDLE WAS BEING THREADED INTO THE CAPIO DEVICE, IT IS LIKELY THE USER APPLIED EXCESSIVE FORCE TO THE DEVICE DURING LOADING. HANDLING DAMAGE CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING PREPARATION FOR A PINNACLE ANTERIOR/APICAL PELVIC FLOOR REPAIR KIT PLACEMENT PROCEDURE, AS THE LEG ASSEMBLY WAS BEING LOADED INTO THE CAPIO DEVICE, THE SUTURE DETACHED, OUTSIDE THE PATIENT. THE PHYSICIAN REMOVED THE DEVICE FROM USE AND COMPLETED THE PROCEDURE WITH ANOTHER PINNACLE ANTERIOR/APICAL PELVIC FLOOR REPAIR KIT. THERE WAS NO IMPACT TO THE PATIENT, WHO IS OVER 18 YEARS OLD AND WAS STABLE AT THE CONCLUSION OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING PREPARATION FOR A PINNACLE ANTERIOR/APICAL PELVIC FLOOR REPAIR KIT PLACEMENT PROCEDURE, AS THE LEG ASSEMBLY WAS BEING LOADED INTO THE CAPIO DEVICE, THE SUTURE DETACHED, OUTSIDE THE PATIENT. THE PHYSICIAN REMOVED THE DEVICE FROM USE AND COMPLETED THE PROCEDURE WITH ANOTHER PINNACLE ANTERIOR/APICAL PELVIC FLOOR REPAIR KIT. THERE WAS NO IMPACT TO THE PATIENT, WHO IS OVER 18 YEARS OLD AND WAS STABLE AT THE CONCLUSION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122496 PINNACLE PELVIC FLOOR REPAIR KITS MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317050

    Patients

    Seq Age Sex Outcome Treatment
    1