BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM CATRX ASPIRATION CATHETER

    MDR report key: 19112353 · Received April 15, 2024

    Report

    Report Number
    3005168196-2024-00145
    Event Type
    Malfunction
    Date Received
    April 15, 2024
    Date of Event
    March 14, 2024
    Report Date
    June 13, 2024
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEX
    UDI-DI
    00814548017556
    PMA / PMN Number
    K220683
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. H3 OTHER TEXT : PLACEHOLDER.

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE RETURNED CATRX REVEALED THAT THE DEVICE WAS KINKED ON THE PROXIMAL SHAFT. THIS IS LIKELY THE REPORTED FRACTURE. IF THE CATRX IS ADVANCED AGAINST RESISTANCE, DAMAGE SUCH AS THIS MAY OCCUR. BASED ON THE REPORTED EVENT, THE ROOT CAUSE OF THE RESISTANCE COULD NOT BE DETERMINED. FURTHER EVALUATION OF THE DEVICE REVEALED BENDS ALONG THE LENGTH OF THE CATHETER. THIS DAMAGE WAS INCIDENTAL TO THE COMPLAINT AND LIKELY 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.

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTION WAS INCORRECTLY REPORTED ON THE INITIAL MFR REPORT AND IS BEING CORRECTED ON THIS FOLLOW-UP #02 MFR REPORT: 3005168196-2024-00145. 1. SECTION D. BOX 4. UNIQUE IDENTIFIER. PLEASE NOTE THAT THE FOLLOWING SECTION WAS INADVERTENTLY MISSED ON THE FOLLOW-UP #01 MFR REPORT AND IS BEING INCLUDED ON THIS FOLLOW-UP #02 MFR REPORT: 3005168196-2024-00145. 1. SECTION B. BOX 5. DESCRIBE EVENT OR PROBLEM PLEASE NOTE THAT THE FOLLOWING STATEMENT IN SECTION H. BOX 10./11. NARRATIVE/CORRECTED DATA WAS INADVERTENTLY MISSED IN THE FOLLOW-UP #01 MFR REPORT AND IS BEING INCLUDED ON THIS FOLLOW-UP #02 MFR REPORT: 3005168196-2024-00145. NOTE: BASED ON THE INVESTIGATION FINDINGS, THIS IS NOT CONSIDERED A REPORTABLE EVENT. THIS EVENT DID NOT AND, IF IT WERE TO RECUR, IT WOULD NOT CAUSE OR CONTRIBUTE TO SERIOUS DETERIORATION OR DEATH.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX) AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY COMPLETED ONE PASS USING THE CATRX. WHILE MAKING THE SECOND PASS, THE PHYSICIAN FRACTURED THE CATRX. THEREFORE, THE CATRX WAS REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE COMPLETION OF THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX) AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY COMPLETED ONE PASS USING THE CATRX. WHILE MAKING THE SECOND PASS, THE PHYSICIAN KINKED THE PROXIMAL END OF THE CATRX. THEREFORE, THE CATRX WAS REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE COMPLETION OF THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1446584 INDIGO SYSTEM CATRX ASPIRATION CATHETER QEX, QEW QEX PENUMBRA, INC. F00008077 00814548017556

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male