BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM CATRX ASPIRATION CATHETER

    MDR report key: 11930911 · Received June 3, 2021

    Report

    Report Number
    3005168196-2021-01219
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Date of Event
    May 8, 2021
    Report Date
    June 29, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEX
    UDI-DI
    00814548017556
    PMA / PMN Number
    K163618
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE RETURNED CATRX REVEALED A PUNCTURE TEAR IN THE GUIDEWIRE LUMEN. IF A GUIDEWIRE IS FORCEFULLY ADVANCED INTO THE GUIDEWIRE LUMEN AT AN EXTREME ANGLE, DAMAGE SUCH AS THIS MAY OCCUR, AND RESISTANCE MAY BE EXPERIENCED DURING ADVANCEMENT. DURING FUNCTIONAL TESTING, A DEMONSTRATION GUIDEWIRE WAS ADVANCED THROUGH THE TEAR IN THE GUIDEWIRE LUMEN, AND THE CATRX WAS ATTEMPTED TO BE ADVANCED THROUGH THE HUB OF A DEMONSTRATION BENCHMARK BUT WAS UNSUCCESSFUL. THE GUIDEWIRE WAS CAREFULLY ADVANCED THROUGH THE GUIDEWIRE LUMEN, THEN THE CATRX WITH THE GUIDEWIRE WITHIN ITS LUMEN WAS ABLE TO ADVANCE THROUGH THE BENCHMARK WITHOUT AN ISSUE. PENUMBRA CATHETERS ARE 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. H3 OTHER TEXT : PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION RESULTS ARE PENDING. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), NON-PENUMBRA GUIDE CATHETER AND 0.14 EXTRA SUPPORT GUIDEWIRE. DURING THE PROCEDURE, THE CATRX WAS LOADED ONTO A SUPPORT GUIDEWIRE AND WOULD NOT ADVANCE PAST THE ROTATING HEMOSTASIS VALVE (RHV). SUBSEQUENTLY, THE CATRX AND GUIDE CATHETER WERE REMOVED. THE PHYSICIAN ATTEMPTED TO RE-ADVANCE THE SAME CATRX THROUGH A NEW GUIDE CATHETER, BUT THE CATRX STILL WOULD NOT ADVANCE PAST THE RHV. THEREFORE, THE CATRX WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CATRX AND THE SECOND GUIDE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829086 INDIGO SYSTEM CATRX ASPIRATION CATHETER QEX, QEW QEX PENUMBRA, INC. CATRXKIT F100749 00814548017556

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR