BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM ASPIRATION CATHETER 7

    MDR report key: 11935441 · Received June 3, 2021

    Report

    Report Number
    3005168196-2021-01244
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Date of Event
    May 7, 2021
    Report Date
    May 7, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    UDI-DI
    00815948023970
    PMA / PMN Number
    K193595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED CAT7 CONFIRMED AN OVALIZATION NEAR ITS DISTAL TIP. IF THE INTRODUCER SHEATH (PROVIDED BY PENUMBRA) IS NOT USED TO PROTECT THE DISTAL SHAFT OF THE CATHETER DURING INSERTION INTO ANOTHER DEVICE, AND THE CAT7 IS FORCEFULLY GRIPPED OR PINCHED DURING INSERTION, DAMAGE SUCH AS THIS 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.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT BRACHIAL VEIN USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE INSERTING THE CAT7 INTO THE SHEATH, THE PHYSICIAN NOTICED THAT THE DISTAL TIP OF THE CAT7 WAS OVALIZED, AND THEREFORE, THE CAT7 COULD NOT ADVANCE PAST THE HUB OF THE SHEATH. CONSEQUENTLY, THE CAT7 WAS REMOVED AND NOT USED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT METHOD. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823435 INDIGO SYSTEM ASPIRATION CATHETER 7 QEW QEW PENUMBRA, INC. CAT7DKIT-A C24801 00815948023970

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR