BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER

    MDR report key: 3885042 · Received June 19, 2014

    Report

    Report Number
    3005168196-2014-00416
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 22, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K090752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: THE 5MAXACE CATHETER IS KINKED APPROXIMATELY 27.0 CM AND 103.0 CM FROM THE HUB. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATES THAT THE 5MAXACE CATHETER WAS KINKED BY TIGHTENING THE RHV ONTO THE CATHETER TOO TIGHT. EVALUATION OF THE RETURNED DEVICE CONFIRMED TWO KINKS IN THE CATHETER SHAFT. THE OBSERVED DAMAGE IS CONSISTENT WITH OVER TIGHTENING THE RHV ON THE CATHETER DURING USE. THESE DEVICES ARE 100% VISUALLY INSPECTED FOR DAMAGE DURING PACKAGING.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER. DURING THE PROCEDURE, THE PHYSICIAN TIGHTENED THE ROTATING HEMOSTATIC VALVE (RHV) TOO TIGHT AND CAUSED THE 5MAX ACE REPERFUSION CATHETER TO KINK. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT AND THE PROCEDURE WAS COMPLETE USING A DIFFERENT CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362056 PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER NRY NRY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1