BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDIGO SYSTEM CATRX ASPIRATION CATHETER

    MDR report key: 9707811 · Received February 13, 2020

    Report

    Report Number
    3005168196-2020-00185
    Event Type
    Injury
    Date Received
    February 13, 2020
    Date of Event
    January 21, 2020
    Report Date
    January 21, 2020
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEX
    UDI-DI
    00814548017556
    PMA / PMN Number
    K163618
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE DEVICE ASSOCIATED WITH THIS COMPLAINT WAS EXPECTED TO BE RETURNED; HOWEVER, ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DEVICE WAS DISPOSED OF AND IS NO LONGER AVAILABLE FOR RETURN. THEREFORE, WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT TIBIAL VESSELS USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE CATRX BROKE AND A SEGMENT OF THE CATHETER BECAME LODGED INSIDE THE PATIENT'S RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE SEGMENT WAS PULLED TO THE LEFT COMMON FEMORAL ARTERY USING A SNARE AND SURGICAL CUT DOWN WAS PERFORMED TO RETRIEVE THE SEGMENT. THE PROCEDURE WAS THEN ENDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172497 INDIGO SYSTEM CATRX ASPIRATION CATHETER QEX QEX PENUMBRA, INC. CATRXKIT F94127 00814548017556

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention