BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM 5MAXACE REPERFUSION CATHETER

    MDR report key: 3851382 · Received June 5, 2014

    Report

    Report Number
    3005168196-2014-00361
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K090752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    RESULT: THE 5MAXACE CATHETER WAS FRACTURED APPROXIMATELY 91.5 CM FROM THE HUB. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLIANT INDICATES THAT THE 5MAXACE CATHETER WAS BROKEN WHEN THE PACKAGE WAS OPENED. EVALUATION OF THE RETURNED DEVICE CONFIRMED A FRACTURE IN THE PROXIMAL SHAFT OF THE CATHETER. THIS TYPE OF DAMAGE TYPICALLY OCCURS WHEN THE DEVICE IS IMPROPERLY HANDLED DURING REMOVAL FROM THE PACKAGING. IF THE CATHETER IS REMOVED FROM THE PACKAGING HOOP AT AN ANGLE, THE SHAFT MAY FRACTURE DUE TO EXCESS FORCE AND BENDING THE CATHETER. THESE DEVICES ARE 100% VISUALLY INSPECTED DURING PROCESSING. 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. DURING PREPARATION FOR THE PROCEDURE, AFTER REMOVING THE DEVICE FROM THE PACKAGING AND UPON INSPECTION, THE OPERATOR FOUND THAT THE DEVICE WAS BROKEN BETWEEN THE GREY PART AND THE PURPLE PART. THE DEVICE WAS NOT USED ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329971 PENUMBRA SYSTEM 5MAXACE REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F40897

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR