BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM ASPIRATION CATHETER 6

    MDR report key: 11821608 · Received May 13, 2021

    Report

    Report Number
    3005168196-2021-01032
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Date of Event
    April 8, 2021
    Report Date
    April 15, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    PMA / PMN Number
    K192833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PERONEAL ARTERY TO TREAT AN ACUTE LIMB ISCHEMIA USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE INSERTING THE CAT6 INTO THE SHEATH USING THE PEEL AWAY SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE DISTAL TIP OF THE CAT6 KINKED; THEREFORE, THE CAT6 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716721 INDIGO SYSTEM ASPIRATION CATHETER 6 QEW QEW PENUMBRA, INC. F99616

    Patients

    Seq Age Sex Outcome Treatment
    1