BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER

    MDR report key: 4866849 · Received June 24, 2015

    Report

    Report Number
    3005168196-2015-00619
    Event Type
    Malfunction
    Date Received
    June 24, 2015
    Date of Event
    May 27, 2015
    Report Date
    May 27, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K133317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    CORRECTION: K133317.

    Additional Manufacturer Narrative · 1

    RESULT: THE 5MAX ACE WAS KINKED APPROXIMATELY 1.0 CM FROM THE HUB UNDERNEATH THE STRAIN RELIEF. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATED UPON REMOVAL FROM THE PACKAGING, THE 5MAX ACE CATHETER WAS FOUND "KINKED AND BROKEN" AND WAS NOT USED. EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE 5MAX ACE WAS KINKED. THIS TYPE OF DAMAGE TYPICALLY OCCURS DUE TO IMPROPER HANDLING DURING REMOVAL FROM THE PACKAGING. IF THE DEVICE IS REMOVED AT AN ANGLE WHILE FORCE IS APPLIED, THE STRAIN RELIEF MAY KINK DUE TO EXCESS FORCE AND BENDING. THESE DEVICES ARE 100% VISUALLY INSPECTED FOR DAMAGE DURING PROCESS INSPECTION. 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

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER. UPON REMOVAL FROM THE PACKAGING, A 5MAX ACE CATHETER WAS FOUND FRACTURED NEAR THE PROXIMAL SHAFT AND WAS NOT USED. THE PROCEDURE SUCCESSFULLY CONTINUED USING A NEW PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409876 PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F63207

    Patients

    Seq Age Sex Outcome Treatment
    1