BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 041

    MDR report key: 3971911 · Received July 31, 2014

    Report

    Report Number
    3005168196-2014-00501
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 4, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K090752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: THE CATHETER IS OVALIZED APPROXIMATELY 1.0, 2.0, 17.0, 39.0, 72.0, AND KINKED 90.0 CM FROM THE DISTAL TIP. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATES THAT SUCTION DURING THE ASPIRATION WAS NOT SMOOTH. THE CATHETER WAS REMOVED AND SEVERAL KINKS WERE FOUND. EVALUATION OF THE RETURNED DEVICE CONFIRMED SEVERAL OVALIZATIONS AND A KINK ALONG THE LENGTH OF THE DISTAL CATHETER SHAFT. THIS DAMAGE IS COMMONLY OBSERVED WHEN THE PRODUCT IS MISHANDLED DURING PREPARATION FOR USE OR DURING MANIPULATION IN THE PATIENT. THESE DEVICES ARE 100% INSPECTED FOR DAMAGE DURING PROCESSING. THIS DAMAGE WAS NOT NOTED UPON INSPECTION OF THE DEVICE OUT OF THE PACKAGING BEFORE INSERTION INTO THE PATIENT. 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 041. DURING THE PROCEDURE, THE PHYSICIAN NOTED THAT THE SUCTION OF THE PENUMBRA SYSTEM REPERFUSION CATHETER 041 WAS NOT SMOOTH. THE PENUMBRA SYSTEM REPERFUSION CATHETER 041 WAS REMOVED AND WAS FOUND TO BE KINKED IN SEVERAL PARTS. THE PATIENT WAS CURED WITH ANOTHER PENUMBRA CATHETER. THERE IS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446436 PENUMBRA SYSTEM REPERFUSION CATHETER 041 NRY NRY PENUMBRA, INC. F24943

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR