BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 2102217 · Received May 17, 2011

    Report

    Report Number
    3005168196-2011-00224
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    PENUMBRA INC.
    Product Code
    HCG
    PMA / PMN Number
    K103305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE PUSHER SHOWED THAT THE PROXIMAL END OF THE HYPOTUBE WAS FRACTURED AND THE PROXIMAL-MOST 15-20 CM WAS NOT PRESENT. FURTHERMORE, NEITHER THE PROXIMAL END OF THE PULL WIRE NOR THE PULL TUBE WAS PRESENT. THESE OBSERVATIONS ARE CONSISTENT WITH THE COMPLAINT DESCRIPTION THAT THE PHYSICIAN PURPOSEFULLY BROKE THE PROXIMAL HYPOTUBE AFTER THE PULL WIRE/PULL TUBE FRACTURED WHILE ATTEMPTING TO OVERCOME EXCESSIVE FRICTION DURING THE DETACHMENT PROCESS. THE DISTAL END OF THE PUSHER WAS EXAMINED UNDER MAGNIFICATION. OBSERVATIONS WERE CONSISTENT WITH A PROPERLY MANUFACTURED DEVICE. HOWEVER, THE PET BUMP APPEARED TO BE DEFORMED AND WEDGED AGAINST THE DISTAL DETACHMENT TIP, WHICH IS A VISUAL STANDARD THAT WOULD BE CAUSE FOR REJECTION DURING QUALITY INSPECTION. THE INTERACTION BETWEEN THE PET BUMP AND DISTAL DETACHMENT TIP COULD REQUIRE TOO MUCH FORCE FOR THE DOCTOR TO OVERCOME DURING THE DETACHMENT PROCESS. THE DEFORMATION IN THE PET BUMP CAUGHT ON THE DISTAL DETACHMENT TIP EDGE AND KEPT THE PULL WIRE IN PLACE, PREVENTING COIL DETACHMENT. THE LOCATION AND STRUCTURE OF THE DEFORMATION SUGGESTS THAT THE DAMAGE WAS CAUSED BY PUSHING THE INTERNAL PULL WIRE AGAINST THE DISTAL DETACHMENT TIP. THIS COULD HAVE BEEN CAUSED BY EXCESSIVE COMPRESSION FORCE DURING USE. THIS FEATURE IS INSPECTED POST ASSEMBLY AND IMMEDIATELY PRIOR TO THE FINAL PACKAGING OF THE DEVICE. ANY DEFECT OF THIS NATURE WOULD BE COMPARED TO VISUAL REFERENCES AND BE REJECTED, THEREFORE IT IS UNLIKELY THAT THIS DEFECT WAS IN THE DEVICE PRIOR TO USE. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    DURING A CASE, FIVE PENUMBRA COIL 400S WERE DEPLOYED INTO THE PT'S ANEURYSM. FOUR OF THE COILS WERE DETACHED, BUT REQUIRED MULTIPLE ATTEMPTS TO DETACH. ONE COIL COULD NOT BE DETACHED AND WAS REMOVED FROM THE PT. THE PT'S ANEURYSM WAS SUCCESSFULLY TREATED. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2011-00220 THROUGH 3005168196-2011-00226.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA INC. F19682

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR