BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER

    MDR report key: 5081752 · Received September 16, 2015

    Report

    Report Number
    3005168196-2015-00896
    Event Type
    Malfunction
    Date Received
    September 16, 2015
    Date of Event
    August 17, 2015
    Report Date
    August 17, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    UDI-DI
    00814548012803
    PMA / PMN Number
    K133317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: K133317.

    Additional Manufacturer Narrative · 1

    RESULTS: THE 5MAX ACE WAS KINKED IN THE STRAIN RELIEF APPROXIMATELY 1.0 CM FROM THE HUB. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATED THAT UPON REMOVAL FROM THE PACKAGING, THE 5MAX ACE WAS KINKED AND WAS NOT USED. EVALUATION OF THE RETURNED DEVICE CONFIRMED IT WAS KINKED IN THE STRAIN RELIEF. THIS TYPE OF DAMAGE TYPICALLY OCCURS DUE TO IMPROPER HANDLING DURING REMOVAL FROM THE PACKAGING. IF THE 5MAX ACE IS MANIPULATED FORCEFULLY AT AN ANGLE DURING REMOVAL FROM THE PACKAGING HOOP, THE STRAIN RELIEF MAY KINK DUE TO EXCESS FORCE AND BENDING. THESE DEVICES ARE 100% VISUALLY INSPECTED DURING IN-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, THE 5MAX ACE CATHETER WAS FOUND KINKED AND WAS NOT USED. THE PROCEDURE CONTINUED USING A NEW 5MAX ACE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613140 PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F63365 00814548012803

    Patients

    Seq Age Sex Outcome Treatment
    1