BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM CATRX ASPIRATION CATHETER

    MDR report key: 14581774 · Received June 2, 2022

    Report

    Report Number
    3005168196-2022-00254
    Event Type
    Malfunction
    Date Received
    June 2, 2022
    Date of Event
    May 6, 2022
    Report Date
    August 8, 2022
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEX
    UDI-DI
    00814548017556
    PMA / PMN Number
    K163618
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE RETURNED CATRX CONFIRMED THAT THE CATHETER WAS STRETCHED AND FRACTURED. IF THE CATRX IS RETRACTED AGAINST RESISTANCE, DAMAGE SUCH AS THIS MAY OCCUR. FURTHER EVALUATION REVEALED DAMAGE TO THE CATRX GUIDEWIRE LUMEN. BASED ON THE REPORTED COMPLAINT, THE RETURNED GUIDEWIRE PROLAPSED WHILE RETRACTING THE CATRX THROUGH THE NON-PENUMBRA SHEATH DURING THE PROCEDURE. THIS MAY BE EXPERIENCED IF THE CATRX GUIDEWIRE LUMEN IS ADVANCED OUTSIDE OF THE NON-PENUMBRA SHEATH BEING USED. THIS LIKELY CONTRIBUTED TO THE RESISTANCE EXPERIENCED CONTRIBUTING TO THE STRETCH, SUBSEQUENT FRACTURE AND GUIDEWIRE LUMEN DAMAGE. PENUMBRA PRODUCTS ARE VISUALLY INSPECTED DURING IN-PROCESS INSPECTION AND DURING QUALITY INSPECTION AFTER MANUFACTURING. 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 PERONEAL ARTERY USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN MADE ONE PASS USING THE CATRX. THE PHYSICIAN THEN MADE ANOTHER PASS USING THE CATRX; HOWEVER, WHILE RETRACTING AFTER MAKING THE PASS, THE GUIDEWIRE FOLDED AND THE CATRX BECAME STUCK ON THE FOLDED PORTION OF THE GUIDEWIRE. CONSEQUENTLY, THE PHYSICIAN BROKE THE PROXIMAL END OF THE CATRX; THEREFORE, THE PHYSICIAN REMOVED THE SHEATH CONTAINING THE BROKEN CATRX WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW NON-PENUMBRA CATHETER 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
    1832299 INDIGO SYSTEM CATRX ASPIRATION CATHETER QEX, QEW QEX PENUMBRA, INC. F112352 00814548017556

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female