BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER

    MDR report key: 4181331 · Received October 17, 2014

    Report

    Report Number
    3005168196-2014-00722
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 18, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K090752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: THE PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER WAS FRACTURED APPROXIMATELY 3.5 CM FROM THE HUB. THE CATHETER WAS RETURNED WITH AN RHV ATTACHED TO THE HUB. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATES THAT THE PACKAGE WAS OPENED AND THE CATHETER WAS ALREADY BENT. EVALUATION OF THE RETURNED PRODUCT CONFIRMED THAT THE PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER WAS FRACTURED IN THE PROXIMAL SHAFT. THIS TYPE OF DAMAGE TYPICALLY OCCURS WHEN THE PRODUCT IS IMPROPERLY HANDLED DURING REMOVAL FROM THE PACKAGING OR DURING PREPARATION FOR USE. ALTHOUGH THE COMPLAINT DESCRIBES THIS ISSUE BEING FOUND BEFORE THE DEVICE WAS REMOVED FROM THE PACKAGING, IT IS LIKELY THAT THIS DAMAGE WAS CAUSED BY HANDLING DURING PREPARATION FOR USE AS AN RHV HAD BEEN ATTACHED TO THE DEVICE. THESE DEVICES ARE 100% INSPECTED FOR DAMAGE DURING PROCESSING. 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 THROMBECTOMY PROCEDURE USING PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER. WHILE OPENING THE PACKAGING, THE DOCTOR FOUND THAT THE PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER WAS KINKED.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER. WHILE OPENING THE PACKAGING, THE DOCTOR FOUND THAT THE PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER WAS KINKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660561 PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F39949

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR