BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM CATD ASPIRATION CATHETER

    MDR report key: 8314909 · Received February 7, 2019

    Report

    Report Number
    3005168196-2019-00193
    Event Type
    Malfunction
    Date Received
    February 7, 2019
    Date of Event
    January 8, 2019
    Report Date
    January 8, 2019
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DXE
    PMA / PMN Number
    K142870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS: THE RETURNED CATD WAS KINKED AT APPROXIMATELY 41.0 CM FROM THE HUB. CONCLUSIONS: EVALUATION OF THE RETURNED CATD CONFIRMED A KINK ON THE DISTAL SHAFT OF THE CATHETER. IF THE CATHETER IS FORCEFULLY REMOVED FROM THE PACKAGING TRAY AT EXTREME ANGLES OR OTHERWISE MISHANDLED DURING PREPARATION, DAMAGE SUCH AS A KINK MAY OCCUR. PENUMBRA CATHETERS ARE INSPECTED DURING IN-PROCESS INSPECTION AND DURING QUALITY INSPECTION AFTER MANUFACTURING. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    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. ADDITIONAL 510(K)#S THAT ALSO APPLY TO THIS COMPLAINT: K160533, K161523.

    Description of Event or Problem · 1

    DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF WAS INSPECTING AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD) AND FOUND A KINK NEAR THE DISTAL END OF THE CATD. THE DAMAGE TO THE CATD WAS FOUND PRIOR TO USE AND THEREFORE IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER CATD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108695 INDIGO SYSTEM CATD ASPIRATION CATHETER DXE DXE PENUMBRA, INC. F83400

    Patients

    Seq Age Sex Outcome Treatment
    1