BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDIGO SYSTEM CATRX ASPIRATION CATHETER

    MDR report key: 18636956 · Received February 3, 2024

    Report

    Report Number
    3005168196-2024-00038
    Event Type
    Injury
    Date Received
    February 3, 2024
    Date of Event
    January 8, 2024
    Report Date
    February 2, 2024
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEX
    UDI-DI
    00814548017556
    PMA / PMN Number
    K220683
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE RETURNED CATRX CONFIRMED A FRACTURE. FURTHER EVALUATION REVEALED THAT THE CATHETER WAS KINKED AT THE FRACTURED LOCATION, INDICATING THAT THE DEVICE LIKELY KINKED PRIOR TO FRACTURING. THIS DAMAGE TYPICALLY OCCURS IF THE DEVICE IS ADVANCED AGAINST RESISTANCE. THE DEVICE MAY BECOME KINKED AND MAY SUBSEQUENTLY FRACTURE. FURTHER EVALUATION ALSO REVEALED KINKS AND OVALIZATIONS ALONG THE LENGTH OF THE DEVICE. THIS DAMAGE WAS INCIDENTAL TO THE COMPLAINT AND LIKELY OCCURRED DURING REMOVAL OF THE DEVICE FROM THE PROCEDURE AND DURING PACKAGING FOR RETURN TO PENUMBRA. PENUMBRA DEVICES ARE VISUALLY 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. H3 OTHER TEXT : PLACEHOLDER.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA), POPLITEAL ARTERY, AND ANTERIOR TIBIAL ARTERY USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), A NON-PENUMBRA SHEATH, A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS USING THE CATRX. THE CATRX WAS REMOVED TO PERFORM AN ANGIOGRAM. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE CATRX WAS FRACTURED AT THE DISTAL END. IT WAS REPORTED THAT THE ANGIOGRAM REVEALED THAT THE DISTAL END OF THE CATRX MIGRATED TO THE DISTAL ANTERIOR TIBIAL ARTERY. THE PHYSICIAN ATTEMPTED TO REMOVE THE FRACTURED CATRX DISTAL END USING A SNARE DEVICE; HOWEVER, THE CATRX DISTAL END COULD NOT BE REMOVED. THE THROMBECTOMY PROCEDURE HAD ENDED AT THIS POINT. THE PATIENT WAS TAKEN TO ANOTHER HOSPITAL AND AN OPEN SURGERY WAS PERFORMED TO REMOVE THE FRACTURED DISTAL END OF THE CATRX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1572676 INDIGO SYSTEM CATRX ASPIRATION CATHETER QEX, QEW QEX PENUMBRA, INC. F00007857 00814548017556

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention