BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM CATRX ASPIRATION CATHETER

    MDR report key: 11749970 · Received April 29, 2021

    Report

    Report Number
    3005168196-2021-00908
    Event Type
    Malfunction
    Date Received
    April 29, 2021
    Date of Event
    September 21, 2020
    Report Date
    July 13, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEX
    UDI-DI
    00814548017556
    PMA / PMN Number
    K163618
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTION WAS UPDATED FOR CLARIFICATION: 1. SECTION B. BOX 5. DESCRIBE EVENT OR PROBLEM. EVALUATION OF THE RETURNED CATRX REVEALED A PROXIMAL SHAFT FRACTURE. IF THE DEVICE IS FORCEFULLY MISHANDLED AT AN EXTREME ANGLE DURING ADVANCEMENT, DAMAGE SUCH AS A KINK AND SUBSEQUENT FRACTURE MAY OCCUR. FURTHER EVALUATION OF THE DEVICE REVEALED AN ADDITIONAL FRACTURE IN ITS MID-SHAFT. THIS DAMAGE WAS LIKELY INCIDENTAL TO THE COMPLAINT AND MAY HAVE OCCURRED DURING PACKAGING 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. H3 OTHER TEXT : PLACEHOLDER.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT CORONARY ARTERY USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), A GUIDING CATHETER AND A SHORT SHEATH. DURING THE PROCEDURE, WHILE ADVANCING THE CATRX INTO THE CORONARY VESSEL, THE PHYSICIAN FRACTURED THE PROXIMAL END OF THE CATRX. THEREFORE, THE CATRX WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CATRX, THE SAME GUIDING CATHETER, AND THE SAME SHORT SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR RETURN. 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 RIGHT CORONARY ARTERY USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), A GUIDING CATHETER AND A SHORT SHEATH. DURING THE PROCEDURE, WHILE ADVANCING THE CATRX INTO THE CORONARY VESSEL, THE PHYSICIAN KINKED THE PROXIMAL END OF THE CATRX. THEREFORE, THE CATRX WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CATRX, THE SAME GUIDING CATHETER, AND THE SAME SHORT SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642658 INDIGO SYSTEM CATRX ASPIRATION CATHETER QEX, QEW QEX PENUMBRA, INC. CATRXKIT F97616 00814548017556

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR