BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER

    MDR report key: 4854241 · Received June 18, 2015

    Report

    Report Number
    3005168196-2015-00602
    Event Type
    Malfunction
    Date Received
    June 18, 2015
    Date of Event
    May 14, 2015
    Report Date
    May 21, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K133317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: THE 5MAX ACE WAS FRACTURED UNDERNEATH THE STRAIN RELIEF, APPROXIMATELY 1.1 CM FROM THE HUB. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATED THAT UPON REMOVAL FROM PACKAGING, THE PROXIMAL SHAFT OF THE 5MAX ACE WAS FOUND FRACTURED NEAR THE HUB. THIS OCCURRED DESPITE THE PHYSICIAN TAKING CARE DURING REMOVAL FROM PACKAGING. EVALUATION OF THE RETURNED DEVICE CONFIRMED A FRACTURE UNDERNEATH THE STRAIN RELIEF. THE ROOT CAUSE OF THIS COMPLAINT COULD NOT BE CONFIRMED. THESE DEVICES ARE 100% VISUALLY INSPECTED 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

    CORRECTION: K133317.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING ON A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER. UPON REMOVAL FROM THE PACKAGING, THE PROXIMAL SHAFT OF THE 5MAX ACE CATHETER WAS FOUND FRACTURED AND WAS NOT USED. THE PROCEDURE CONTINUED USING A NEW 5MAX ACE REPERFUSION CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397194 PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F46425

    Patients

    Seq Age Sex Outcome Treatment
    1