BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER

    MDR report key: 4922935 · Received July 17, 2015

    Report

    Report Number
    3005168196-2015-00698
    Event Type
    Malfunction
    Date Received
    July 17, 2015
    Date of Event
    June 17, 2015
    Report Date
    June 17, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K133317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SECTION UPDATED. CORRECTION: K133317.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. THE HOSPITAL DISCARDED THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER. UPON REMOVAL FROM THE PACKAGING, THE 5MAX ACE CATHETER WAS FOUND BROKEN AND WAS NOT USED. THE PROCEDURE CONTINUED USING A NEW 5MAX ACE CATHETER.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER. UPON REMOVAL FROM THE PACKAGING, THE 5MAX ACE CATHETER WAS FOUND BROKEN AND WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467094 PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F63365

    Patients

    Seq Age Sex Outcome Treatment
    1