BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDIGO SYSTEM CAT RX ASPIRATION CATHETER

    MDR report key: 19008589 · Received March 29, 2024

    Report

    Report Number
    3005168196-2024-00117
    Event Type
    Injury
    Date Received
    March 29, 2024
    Date of Event
    March 5, 2024
    Report Date
    May 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
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. 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 · 0

    PLEASE NOTE THAT THE FOLLOWING SECTION WAS INCORRECTLY REPORTED ON THE INITIAL MFR REPORT AND IS BEING CORRECTED ON THIS FOLLOW-UP #01 MFR REPORT:3005168196-2024-00117 1. SECTION A. BOX 2. DATE OF BIRTH.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE TIBIAL ARTERY USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS USING THE CATRX. IT WAS REPORTED THAT WHILE REMOVING THE CATRX FROM THE PATIENT, THE CATRX FRACTURED. THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE REMAINING PORTION OF THE CATRX FROM THE TIBIAL VESSEL VIA A PEDAL BRANCH ACCESS POINT. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA BALLOON DEVICE AND THE SAME SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2593137 INDIGO SYSTEM CAT RX ASPIRATION CATHETER QEX,QEW QEX PENUMBRA, INC. F00009260 00814548017556

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Female Required Intervention