BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM CAT RX ASPIRATION CATHETER

    MDR report key: 9526652 · Received December 27, 2019

    Report

    Report Number
    3005168196-2019-02428
    Event Type
    Malfunction
    Date Received
    December 27, 2019
    Date of Event
    December 5, 2019
    Report Date
    December 6, 2019
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEX
    UDI-DI
    00814548017556
    PMA / PMN Number
    K163618
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE DEVICE IN COMPLAINT WAS EXPECTED TO BE RETURNED; HOWEVER, ADDITIONAL INFORMATION RECEIVED FROM THE PENUMBRA SALES REPRESENTATIVE INDICATED THAT THE DEVICE IS NO LONGER AVAILABLE FOR RETURN. THEREFORE, WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. BASED ON THIS INFORMATION, CORRECTIONS WERE MADE TO: 1. SECTION D. BOX 10. DEVICE AVAILABLE FOR EVALUATION? (DO NOT SEND TO FDA) 2. SECTION H. BOX 3. REASON FOR NON-EVALUATION 3. SECTION H. BOX 3. ''OTHER'' REASON FOR NON-EVALUATION THE PRODUCT LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTIONS WERE INCORRECTLY REPORTED ON THE INITIAL MFR REPORT AND ARE BEING CORRECTED ON THIS FOLLOW-UP #02 MFR REPORT:3005168196-2019-02428. 1. SECTION E. BOX 3. OCCUPATION 2. SECTION E. BOX 3. OTHER OCCUPATION (DESCRIPTION).

    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 (RCA) USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX) AND NON-PENUMBRA DIAGNOSTIC CATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY COMPLETED TWO PASSES USING THE CATRX AND DIAGNOSTIC CATHETER. WHILE RETRACTING THE CATRX THROUGH THE DIAGNOSTIC CATHETER AFTER COMPLETION OF THE THIRD PASS, THE PHYSICIAN EXPERIENCED RESISTANCE. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE CATRX WAS DAMAGED AT THE DISTAL END OF THE RAPID EXCHANGE PORT. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER AND THE SAME DIAGNOSTIC CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1321306 INDIGO SYSTEM CAT RX ASPIRATION CATHETER QEX QEX PENUMBRA, INC. CATRXKIT 00814548017556

    Patients

    Seq Age Sex Outcome Treatment
    1