BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM ASPIRATION CATHETER D

    MDR report key: 11254766 · Received January 29, 2021

    Report

    Report Number
    3005168196-2021-00180
    Event Type
    Malfunction
    Date Received
    January 29, 2021
    Date of Event
    January 7, 2021
    Report Date
    January 7, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    UDI-DI
    00815948022423
    PMA / PMN Number
    K142870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL 510(K)#S THAT ALSO APPLY TO THIS COMPLAINT: K160533, K161523. 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 TO TREAT A DEEP VEIN THROMBOSIS (DVT) USING AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE INSERTING THE CATD INTO THE SHEATH, THE PHYSICIAN OVALIZED THE DISTAL TIP OF THE CATD. THEREFORE, THE CATD AND SHEATH WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CATD AND A NEW NON-PENUMBRA SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148318 INDIGO SYSTEM ASPIRATION CATHETER D QEW QEW PENUMBRA, INC. CATD-D H10628 00815948022423

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR