BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM CATRX ASPIRATION CATHETER

    MDR report key: 11638482 · Received April 8, 2021

    Report

    Report Number
    3005168196-2021-00716
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Date of Event
    March 13, 2021
    Report Date
    March 13, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEX
    UDI-DI
    00814548017556
    PMA / PMN Number
    K163618
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED CATRX CONFIRMED A KINK AND REVEALED A FRACTURE NEAR THE MID-SHAFT. IF THE DEVICE IS FORCEFULLY ADVANCED AGAINST RESISTANCE OR IS OTHERWISE MISHANDLED AT EXTREME ANGLES DURING USE, DAMAGE SUCH AS A KINK AND SUBSEQUENT FRACTURE MAY OCCUR. FURTHER EVALUATION REVEALED THAT THE GUIDEWIRE LUMEN WAS DAMAGED ON ITS PROXIMAL END AND THE CATHETER HAD ADDITIONAL BENDS THROUGHOUT ITS LENGTH. THIS DAMAGE WAS LIKELY INCIDENTAL TO THE REPORTED COMPLAINT AND MAY HAVE OCCURRED DURING PACKAGING OF THE DEVICE FOR RETURN TO PENUMBRA. 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.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL ARTERY/ TIBIOPERONEAL (TP) TRUNK USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE CATRX THROUGH THE SHEATH DOWN TO THE LOWER EXTREMITY, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE CATRX WAS KINKED AT THE MID-SHAFT. THE CATRX WOULD NOT ADVANCE FURTHER AND WAS REMOVED. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) 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
    533017 INDIGO SYSTEM CATRX ASPIRATION CATHETER QEX,QEW QEX PENUMBRA, INC. CATRXKIT F93816 00814548017556

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR