BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 054

    MDR report key: 3813007 · Received May 15, 2014

    Report

    Report Number
    3005168196-2014-00308
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    March 14, 2014
    Report Date
    April 16, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K090752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: THE REPERFUSION CATHETER 054 IS KINKED APPROXIMATELY 31.0 CM FROM THE DISTAL TIP. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATES THAT THE OPERATOR DISCOVERED THAT THE MIDDLE PART OF THE REPERFUSION CATHETER 054 WAS KINKED DURING ADVANCEMENT. EVALUATION OF THE RETURNED DEVICE CONFIRMED A KINK IN THE CATHETER SHAFT APPROXIMATELY 31.0 CM FROM THE DISTAL TIP. THIS ISSUE WAS NOT DETECTED OUT-OF-THE-BOX AND WAS LIKELY THE RESULT OF HANDLING DURING USE. IF THE PRODUCT IS IMPROPERLY HANDLED DURING REMOVAL FROM THE PACKAGING OR PREPARATION FOR USE, DAMAGE SUCH AS THIS MAY OCCUR. THESE DEVICES ARE 100% VISUALLY INSPECTED FOR DAMAGE DURING PACKAGING. 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 REPERFUSION CATHETER 054. DURING THE PROCEDURE, THE PHYSICIAN FOUND THAT MIDDLE PART OF THE CATHETER WAS KINKED. THE PHYSICIAN REPLACED THE CATHETER TO COMPLETE THE PROCEDURE WITH NO REPORTED ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290382 PENUMBRA SYSTEM REPERFUSION CATHETER 054 NRY NRY PENUMBRA, INC. F23544

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR