BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER

    MDR report key: 4851539 · Received June 17, 2015

    Report

    Report Number
    3005168196-2015-00578
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Date of Event
    May 18, 2015
    Report Date
    May 19, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K133317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: K133317.

    Additional Manufacturer Narrative · 1

    RESULTS: THE 3MAX WAS FRACTURED APPROXIMATELY 33.0 CM FROM THE HUB. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATED THAT UPON REMOVAL FROM THE PACKAGING, THE 3MAX WAS BENT AND WAS NOT USED. EVALUATION OF THE RETURNED DEVICE REVEALED IT WAS FRACTURED. THIS TYPE OF DAMAGE TYPICALLY OCCURS DUE TO IMPROPER HANDLING DURING REMOVAL FROM PACKAGING. IF THE 3MAX IS REMOVED FROM THE PACKAGING HOOP FORCEFULLY OR AT AN ANGLE, THE 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

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

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER. UPON REMOVAL FROM THE PACKAGING, THE 3MAX CATHETER BECAME KINKED AND WAS NOT USED. THE PROCEDURE CONTINUED USING A NEW PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393244 PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F29673

    Patients

    Seq Age Sex Outcome Treatment
    1