BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM ASPIRATION CATHETER 12

    MDR report key: 11369893 · Received February 23, 2021

    Report

    Report Number
    3005168196-2021-00336
    Event Type
    Malfunction
    Date Received
    February 23, 2021
    Date of Event
    January 28, 2021
    Report Date
    January 28, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    UDI-DI
    00815948022577
    PMA / PMN Number
    K192981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTIONS WERE INCORRECTLY REPORTED ON THE INITIAL MFR REPORT AND ARE BEING CORRECTED ON THIS FOLLOW-UP #01 MFR REPORT:3005168196-2021-00336.

    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 SUPERFICIAL FEMORAL VEIN (SFV) USING A ROTATING HEMOSTASIS VALVE (RHV) PACKAGED WITH AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12) AND AN INDIGO SYSTEM SEPARATOR 12 (SEP12). DURING THE PROCEDURE, AFTER THE RHV WAS OPENED AND CLOSED NUMEROUS TIMES, THE RHV VALVE CAP FELL OFF WHILE ATTEMPTING TO INSERT THE SEP12. IT WAS REPORTED THAT THE RHV COULD NOT BE RE-SEALED; THEREFORE, THE RHV WAS NO LONGER USED. THE PROCEDURE WAS COMPLETED USING A NEW RHV, THE SAME CAT12 AND THE SAME SEP12. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266520 INDIGO SYSTEM ASPIRATION CATHETER 12 QEW QEW PENUMBRA, INC. LITNG12HTORQ115-A F99285 00815948022577

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR