BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDIGO SYSTEM CATRX ASPIRATION CATHETER

    MDR report key: 11939447 · Received June 4, 2021

    Report

    Report Number
    3005168196-2021-01253
    Event Type
    Injury
    Date Received
    June 4, 2021
    Date of Event
    May 7, 2021
    Report Date
    May 7, 2021
    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
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE RETURNED CATRX CONFIRMED A FRACTURE. EVALUATION ALSO REVEALED A STRETCHED REGION OF THE CATHETER SPANNING ACROSS THE FRACTURE LOCATION. THIS DAMAGE INDICATES THE FRACTURE WAS LIKELY DUE TO THE CATHETER BEING RETRACTED AGAINST RESISTANCE. IF THE DEVICE IS FORCEFULLY RETRACTED AGAINST RESISTANCE, THE CATHETER MAY BECOME STRETCHED AND FRACTURE. THE ROOT CAUSE OF RESISTANCE COULD NOT BE DETERMINED. 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. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 3005168196-2021-01252 H3 OTHER TEXT : PLACEHOLDER.

    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. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 3005168196-2021-01252.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL AND PERONEAL ARTERIES USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6), AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), A 7F NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING A CAT6 TO THE TARGET VESSEL USING THE NON-PENUMBRA SHEATH, THE CAT6 WOULD NOT ADVANCE THROUGH THE TIBIAL ARTERY; THEREFORE, THE CAT6 WAS REMOVED. UPON REMOVAL, IT WAS NOTED THAT THE DISTAL TIP OF THE CAT6 WAS KINKED. NEXT, THE PHYSICIAN ADVANCED THE CATRX OVER THE GUIDEWIRE THROUGH THE GUIDEWIRE LUMEN AND COMPLETED APPROXIMATELY FIVE TO SEVEN PASSES IN THE TARGET VESSEL. WHILE RETRACTING THE CATRX AFTER THE COMPLETION OF THE LAST PASS, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED UNDER FLUOROSCOPY THAT THE DISTAL TIP OF THE CATRX BROKE OFF. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE DETACHED DISTAL TIP OF THE CATRX. THE PROCEDURE WAS COMPLETED USING A NEW CATRX, THE SAME SHEATH, AND ANOTHER GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834591 INDIGO SYSTEM CATRX ASPIRATION CATHETER QEX, QEW QEX PENUMBRA, INC. CATRXKIT F102944 00814548017556

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Required Intervention