BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER

    MDR report key: 4869106 · Received June 25, 2015

    Report

    Report Number
    3005168196-2015-00655
    Event Type
    Malfunction
    Date Received
    June 25, 2015
    Date of Event
    June 5, 2015
    Report Date
    June 5, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K133317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: THE 5MAX ACE WAS FRACTURED APPROXIMATELY 93.0 CM FROM THE HUB. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATED THAT UPON REMOVAL FROM THE PACKAGING, THE 5MAX ACE WAS FRACTURED AND WAS NOT USED. EVALUATION OF THE RETURNED DEVICE CONFIRMED A FRACTURE IN THE PROXIMAL SHAFT. THIS TYPE OF DAMAGE TYPICALLY OCCURS DUE TO IMPROPER HANDLING DURING REMOVAL FROM PACKAGING. IF THE 5MAX ACE IS REMOVED FROM THE PACKAGING HOOP FORCEFULLY OR AT AN ANGLE, THE CATHETER SHAFT MAY FRACTURE 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.

    Additional Manufacturer Narrative · 1

    CORRECTION: K133317.

    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, THE 5MAX ACE CATHETER WAS FOUND BROKEN 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
    412745 PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F63177

    Patients

    Seq Age Sex Outcome Treatment
    1