BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM CATD ASPIRATION CATHETER

    MDR report key: 10462555 · Received August 27, 2020

    Report

    Report Number
    3005168196-2020-01296
    Event Type
    Malfunction
    Date Received
    August 27, 2020
    Date of Event
    August 4, 2020
    Report Date
    August 4, 2020
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DXE
    PMA / PMN Number
    K142870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS: THE CATD WAS KINKED APPROXIMATELY 39.5 CM FROM THE HUB. CONCLUSIONS: EVALUATION OF THE RETURNED CATD CONFIRMED THAT THE CATHETER WAS KINKED. IF THE CATD IS FORCEFULLY MISHANDLED DURING USE, DAMAGE SUCH AS A KINK MAY OCCUR. DURING THE FUNCTIONAL TEST, THE CATD WAS CONNECTED TO A DEMONSTRATION ASPIRATION TUBING, CANISTER, AND PUMP. THE PUMP WAS POWERED ON AND FLUID WAS ASPIRATED INTO THE CANISTER. PENUMBRA CATHETERS ARE VISUALLY INSPECTED DURING IN-PROCESS INSPECTION AND DURING QUALITY 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

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD). DURING THE PROCEDURE, WHILE PERFORMING ASPIRATION, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE DISTAL END OF THE CATD KINKED AND WAS NO LONGER ASPIRATING THE CLOT. THEREFORE, THE CATD WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER CATD. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925648 INDIGO SYSTEM CATD ASPIRATION CATHETER DXE DXE PENUMBRA, INC. F89811

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR