BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER

    MDR report key: 4922941 · Received July 17, 2015

    Report

    Report Number
    3005168196-2015-00699
    Event Type
    Malfunction
    Date Received
    July 17, 2015
    Date of Event
    June 18, 2015
    Report Date
    June 18, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K152541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: K152541.

    Additional Manufacturer Narrative · 1

    RESULT: THE PROXIMAL SHAFT WAS KINKED APPROXIMATELY 34.0 CM FROM THE HUB. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATED THAT THE ACE 64 WAS NOTICED TO BE FRACTURED ABOUT 20-30 CM FROM THE HUB. THE COMPLAINT MENTIONED THAT NO EXCESSIVE FORCE WAS USED DURING THE REMOVAL FROM PACKAGING. EVALUATION OF THE RETURNED DEVICE REVEALED A KINKED PROXIMAL SHAFT. THIS TYPE OF DAMAGE TYPICALLY OCCURS DUE TO IMPROPER HANDLING DURING REMOVAL FROM THE PACKAGING. EVEN THOUGH THE COMPLAINT INDICATED THAT EXCESSIVE FORCE WAS NOT USED, IF DEVICE WAS REMOVAL FROM THE PACKAGING HOOP AT AN ANGLE, DAMAGE SUCH AS THIS MAY OCCUR. 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 ACE 64 REPERFUSION CATHETER. UPON REMOVAL FROM THE PACKAGING, THE ACE 64 CATHETER WAS FOUND BROKEN AND WAS NOT USED. THE PROCEDURE CONTINUED USING A NEW ACE 64 CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466838 PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F64064

    Patients

    Seq Age Sex Outcome Treatment
    1