BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM ASPIRATION CATHETER D

    MDR report key: 10339672 · Received July 29, 2020

    Report

    Report Number
    3005168196-2020-01039
    Event Type
    Malfunction
    Date Received
    July 29, 2020
    Date of Event
    July 6, 2020
    Report Date
    July 6, 2020
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DXE
    UDI-DI
    00815948020481
    PMA / PMN Number
    K142870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    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. ADDITIONAL 510(K)#S THAT ALSO APPLY TO THIS COMPLAINT: K160533, K161523.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE FEMORAL VEIN USING AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE CATD THROUGH THE VALVE OF THE SHEATH USING A PEEL AWAY SHEATH AND COMPLETED APPROXIMATELY EIGHT TO TEN PASSES USING THE CATD. THE PHYSICIAN THEN REMOVED THE CATD AND NOTICED A KINK APPROXIMATELY TWO CENTIMETERS FROM THE DISTAL END OF THE CATD. IT WAS ALSO REPORTED THAT THE CATD WAS BEING AGGRESSIVELY TORQUED, ADVANCED AND RETRACTED. THE PROCEDURE WAS COMPLETED USING A CAT8 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
    805605 INDIGO SYSTEM ASPIRATION CATHETER D DXE DXE PENUMBRA, INC. CATD-C H10046 00815948020481

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR