BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER

    MDR report key: 5104360 · Received September 25, 2015

    Report

    Report Number
    3005168196-2015-00956
    Event Type
    Malfunction
    Date Received
    September 25, 2015
    Date of Event
    August 27, 2015
    Report Date
    August 27, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    UDI-DI
    00814548012803
    PMA / PMN Number
    K133317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: THE PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER (5MAX ACE) WAS KINKED APPROXIMATELY 3.0 CM FROM THE HUB. CONCLUSION: EVALUATION OF THE RETURNED DEVICE CONFIRMED IT WAS KINKED. THIS TYPE OF DAMAGE TYPICALLY OCCURS DUE TO IMPROPER HANDLING DURING REMOVAL FROM THE PACKAGING. IF THE 5MAX ACE IS REMOVED FROM THE PACKAGING HOOP FORCEFULLY AT AN ANGLE, DAMAGE SUCH AS THIS MAY OCCUR. THESE DEVICES ARE 100% VISUALLY INSPECTED DURING IN-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 TO SECTIONS: (B)(6) ,K133317.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION RESULTS ARE PENDING. 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 IN THE INTERNAL CAROTID ARTERY USING THE PENUMBRA SYSTEM 5MAX ACE 132 REPERFUSION CATHETER (5MAX ACE 132). DURING PREPARATION, AFTER REMOVING THE 5MAX ACE 132 FROM ITS PACKAGING AND FLUSHING IT WITH SALINE, THE PHYSICIAN NOTICED THAT IT WAS KINKED AND THE PROXIMAL END OF THE CATHETER APPEARED TO BE DISLODGED FROM THE CATHETER BRAID. THE 5MAX ACE 132 WAS REMOVED AND THE PROCEDURE CONTINUED USING A NEW 5MAX ACE 132. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634315 PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F41040 00814548012803

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR