BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM ASPIRATION CATHETER 7D

    MDR report key: 15263001 · Received August 20, 2022

    Report

    Report Number
    3005168196-2022-00383
    Event Type
    Malfunction
    Date Received
    August 20, 2022
    Date of Event
    July 26, 2022
    Report Date
    August 19, 2022
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    UDI-DI
    00815948023970
    PMA / PMN Number
    K193595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL 510(K)# THAT ALSO APPLY TO THIS COMPLAINT: K210083. 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 · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT ARTERIOVENOUS FISTULA (AVF) VENOUS SEGMENT USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 D (CAT7 D) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE ADVANCING THE CAT7 D THROUGH THE SHEATH, THE PHYSICIAN WAS EXPERIENCING RESISTANCE AND WAS UNABLE TO ADVANCE THE CAT7 D. SUBSEQUENTLY, THE PHYSICIAN KINKED THE CAT7 D AT THE TRANSITION ZONE AND DECIDED TO REMOVE IT. HOWEVER, WHILE REMOVING THE CAT7 D OUT FROM THE SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AGAIN AND BROKE THE CAT7 D INTO TWO SEPARATE PIECES APPROXIMATELY 10 TO 15 CENTIMETERS FROM THE DISTAL END. IT WAS REPORTED THAT THERE WAS ENOUGH OF THE BROKEN PIECE OF THE CAT7 D OUT OF FROM THE SHEATH TO HOLD ONTO TO REMOVE IT. THEREFORE, THE CAT7 D WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW CAT7 D 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
    1941042 INDIGO SYSTEM ASPIRATION CATHETER 7D QEW QEW PENUMBRA, INC. H00000143 00815948023970

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male