BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER

    MDR report key: 4954905 · Received July 30, 2015

    Report

    Report Number
    3005168196-2015-00733
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Date of Event
    June 24, 2015
    Report Date
    June 30, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K133317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: K133317.

    Additional Manufacturer Narrative · 1

    RESULT: THE 4MAX WAS KINKED IN THE PROXIMAL SHAFT APPROXIMATELY 3.5 CM FROM THE HUB. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATED THAT UPON REMOVAL FROM THE PACKAGING, THE 4MAX WAS KINKED. EVALUATION OF THE RETURNED DEVICE CONFIRMED IT WAS KINKED. THIS TYPE OF DAMAGE TYPICALLY OCCURS DUE TO IMPROPER HANDLING DURING THE REMOVAL FROM PACKAGING. IF THE 4MAX IS MANIPULATED FORCEFULLY AT AN ANGLE DURING REMOVAL FROM THE PACKAGING, THE CATHETER SHAFT MAY KINK 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.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER. DURING PREPARATION FOR THE PROCEDURE, THE 4MAX CATHETER WAS FOUND KINKED AND WAS NOT USED. THE PROCEDURE SUCCESSFULLY CONTINUED USING ANOTHER 4MAX REPERFUSION CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498362 PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F46010

    Patients

    Seq Age Sex Outcome Treatment
    1