BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER

    MDR report key: 5066010 · Received September 9, 2015

    Report

    Report Number
    3005168196-2015-00868
    Event Type
    Malfunction
    Date Received
    September 9, 2015
    Date of Event
    July 28, 2015
    Report Date
    August 10, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    UDI-DI
    00814548012803
    PMA / PMN Number
    K133317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE 5MAX ACE WAS FRACTURED UNDER 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 REVEALED THAT THE 5MAX ACE WAS FRACTURED. THIS TYPE OF DAMAGE TYPICALLY OCCURS DUE TO IMPROPER HANDLING DURING REMOVAL FROM THE PACKAGING. IF THE 5MAX ACE IS REMOVED FROM THE PACKAGING HOOP FORCEFULLY AT AN ANGLE, THE STRAIN RELIEF MAY FRACTURE DUE TO EXCESS FORCE AND BENDING. THESE DEVICES ARE 100% VISUALLY INSPECTED DURING IN-PROCESS INSPECTION.

    Additional Manufacturer Narrative · 1

    CORRECTION TO SECTION G5: 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 KINKED AND WAS NOT USED. THE PROCEDURE CONTINUED USING A NEW 5MAX ACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597710 PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F63365 00814548012803

    Patients

    Seq Age Sex Outcome Treatment
    1