BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEPARATOR 032

    MDR report key: 1051443 · Received May 21, 2008

    Report

    Report Number
    3005168196-2008-00010
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    April 15, 2008
    Report Date
    May 21, 2008
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K072718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS INVESTIGATION WAS RETURNED TO PENUMBRA ON 19MAY08. THE LOT NUMBER OF THE DEVICE IS UNKNOWN AND, AS SUCH, A DHR REVIEW COULD NOT BE PERFORMED. THE RESULTS OF THE DEVICE EVALUATION ARE AS FOLLOWS: DEVICE EVALUATION: THE CATHETER FRACTURED (SEPARATED) AT THE PROXIMAL SHAFT (0.041IN ID) / DISTAL SHAFT (0.032IN ID) JOINT. THE FRACTURE OCCURRED AT A LOCATION IN WHICH THE TOPCOAT POLYMER THAT BONDS THE TWO SHAFTS APPEARS TO NOT HAVE BEEN POSITIONED ACCURATELY DURING THE LAMINATION BONDING PROCESS (MANUFACTURING), THEREBY RESULTING IN A WEAKENED JOINT. UNDER THE STRESS OF TORTUOUS ANATOMY, THE WEAKENED JOINT FRACTURED. THERE WAS NO EVIDENCE OF PLASTIC DEFORMATION IN THE FRACTURE ZONE.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS TREATING AN M1 OCCLUSION WITH AN 041 PENUMBRA SYSTEM (SEPARATOR REPERFUSION CATHETER). THE PHYSICIAN REMOVED THE CLOT BURDEN AND DECIDED TO SWITCH TO A PENUMBRA SYSTEM TO REMOVE CLOT FROM AN M2 OCCLUSION. THE PHYSICIAN INSERTED A TERUMO 16 WIRE INTO THE REPERFUSION CATHETER 032, AND NOTICED A CATCH AT THE SHAFT ID TAPER. HE POSITIONED THE CATHETER IN THE ANATOMY AND REMOVED THE GUIDEWIRE. THE PHYSICIAN THEN INSERTED AN 032 SEPARATOR AND AGAIN NOTICED A CATCH AT THE CATHETER ID TAPER. WHILE ADVANCING THE SEPARATOR 032, THE PHYSICIAN NOTED IT "FELT DIFFERENT". HE TRIED TO REMOVE THE REPERFUSION CATHETER 032 AND NOTED THE CATHETER TIP DID NOT WITHDRAW, INDICATING A SEPARATION OF THE REPERFUSION CATHETER 032 SHAFT. THE PHYSICIAN THEN INSERTED A 0.014IN GUIDEWIRE AND PASSED IT THROUGH THE DISTAL LUMEN. HE REMOVED THE PROXIMAL REPERFUSION CATHETER 032 SHAFT AND NOTED THE CATHETER COIL WAS NOT ATTACHED, INDICATING A COMPLETE SEPARATION OF THE REPERFUSION CATHETER 032 AT THE ID TAPER. THE PHYSICIAN WAS ABLE TO SNAG THE PROXIMAL SIDE OF THE SEPARATED DISTAL REPERFUSION CATHETER 032 SHAFT INSIDE THE 6F GUIDE CATHETER WITH A 0.035IN GUIDEWIRE. THE PHYSICIAN NOTED THAT AFTER REMOVING THE DISTAL END OF THE REPERFUSION CATHETER 032 FROM THE PATIENT, HE INADVERTENTLY FLATTENED THE DISTAL SECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEPARATOR 032 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1