BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM ASPIRATION CATHETER D

    MDR report key: 10708694 · Received October 20, 2020

    Report

    Report Number
    3005168196-2020-01791
    Event Type
    Malfunction
    Date Received
    October 20, 2020
    Date of Event
    September 24, 2020
    Report Date
    September 24, 2020
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    UDI-DI
    00815948020481
    PMA / PMN Number
    K142870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 TO TREAT AN OCCLUDED ARTERIOVENOUS (AV) FISTULA USING AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, A PINNACLE SHEATH WAS PLACED IN THE DIALYSIS FISTULA. THE PHYSICIAN THEN EXPERIENCED RESISTANCE AFTER ADVANCING THE CATD A FEW CENTIMETERS THROUGH THE SHEATH. THEREFORE, THE PHYSICIAN REMOVED THE CATD AND NOTICED THE DISTAL TIP TO BE OVALIZED. IT WAS REPORTED THAT THE PHYSICIAN NOTICED THE SHEATH TO BE KINKED UNDER FLUOROSCOPY AND THE CATD BECAME DAMAGED UPON ADVANCING THROUGH THE KINKED SECTION OF THE SHEATH AND, THEREFORE, THE SHEATH WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CATD AND SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173287 INDIGO SYSTEM ASPIRATION CATHETER D QEW QEW PENUMBRA, INC. CATD-C H10288 00815948020481

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR