BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 2103409 · Received May 17, 2011

    Report

    Report Number
    3005168196-2011-00220
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TWO PUSHER ASSEMBLIES WERE RETURNED, AND FOUR COILS WERE DEPLOYED DURING THE CASE. IT IS UNKNOWN FROM WHICH TWO COILS THE RETURNED PUSHERS ORIGINATED. THE PULL WIRE WAS RECESSED PROXIMAL TO THE DISTAL DETACHMENT TIP AND THE PET LOCK AT THE PROXIMAL END WAS BROKEN. THESE OBSERVATIONS INDICATE THAT THE DETACHMENT MECHANISM WAS ACTUATED AND THE COIL WAS DETACHED. THE COMPLAINT STATED THAT THESE COILS WERE DETACHED WITH DIFFICULTY AFTER MULTIPLE ATTEMPTS. THE LIKELY CAUSE OF THIS COMPLAINT WAS EXCESSIVE FRICTION BETWEEN THE PUSHER AND PULL WIRE. IN AN ATTEMPT TO FIND AND ISOLATE FRICTION BETWEEN THESE COMPONENTS, THE PUSHER WAS CUT AT ITS MIDJOINT WITHOUT DAMAGING THE PULL WIRE. THE PUSHER PROXIMAL SHAFT (HYPOTUBE) WAS THEN CAREFULLY PULLED AWAY FROM THE PULL WIRE AND PUSHER DISTAL SHAFT TO SEE IF ANY FRICTION WAS ENCOUNTERED BETWEEN THE PUSHER PROXIMAL SHAFT AND PULL WIRE. THERE WAS NO NOTICEABLE FRICTION. THE PULL WIRE WAS THEN RETRACTED FROM THE PUSHER DISTAL SHAFT TO SEE IF ANY FRICTION WAS ENCOUNTERED BETWEEN THE DISTAL SHAFT AND PULL WIRE. THERE WAS NO NOTICEABLE FRICTION. THE PULL WIRE WAS EXAMINED FOR KINKS OR OTHER DEFORMATIONS. THERE WAS NO EVIDENCE OF DEFORMATIONS. CONCLUSIONS: THE TWO DETACHED PUSHER ASSEMBLIES RETURNED WERE SENT AS EXAMPLES OF PRODUCT THAT DID NOT DETACH THE FIRST TIME USING THE DETACHMENT HANDLE BUT SUCCESSFULLY DETACHED AFTER MULTIPLE ATTEMPTS. THE PUSHERS APPEAR TO BE FULLY FUNCTIONAL WITH NO DEFECTS THAT COULD LEAD TO EXCESSIVE FRICTION. EXCESSIVE TORTUOSITY IN THE PATIENT'S ARTERIES MAY HAVE CONTRIBUTED TO FRICTION BETWEEN THE PUSHER AND PULL WIRE, THEREBY REQUIRING MULTIPLE DETACHMENT ATTEMPTS. 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 PATIENT'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 PATIENT. THE PATIENT'S ANEURYSM WAS SUCCESSFULLY TREATED. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2011-00221 THROUGH 3005168196-2011-00226.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA INC. F19141

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR