BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM ASPIRATION CATHETER 8

    MDR report key: 20057681 · Received August 23, 2024

    Report

    Report Number
    3005168196-2024-00288
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    July 29, 2024
    Report Date
    October 16, 2024
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    UDI-DI
    00815948022324
    PMA / PMN Number
    K193244
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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.

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE RETURNED CAT8 REVEALED THAT THE DISTAL TIP WAS DAMAGED AND THE MARKERBAND WAS DETACHED. THE DISTAL TIP DAMAGE LIKELY CAUSED THE MARKERBAND TO DETACH FROM THE CATHETER DURING THE PROCEDURE. BASED ON THE REPORTED EVENT, THE ROOT CAUSE OF THE DAMAGE COULD NOT BE DETERMINED. THE MARKERBAND WAS NOT RETURNED FOR EVALUATION. FURTHER EVALUATION REVEALED KINKS ALONG THE CATHETER SHAFT. THIS DAMAGE WAS INCIDENTAL TO THE COMPLAINT, AND LIKELY OCCURRED DURING PACKAGING OF THE DEVICE FOR RETURN. 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 PULMONARY ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), A NON-PENUMBRA SHORT SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT8 INTO THE TARGET VESSEL AND SUCCESSFULLY COMPLETED ONE PASS. WHILE REMOVING THE CAT8, THE PHYSICIAN EXPERIENCED RESISTANCE AND UPON REMOVAL, THE PHYSICIAN FOUND THAT THE DISTAL END OF THE CAT8 HAD FRACTURED OFF. THEREFORE, THE CAT8 WAS REMOVED USING A SNARE DEVICE. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1293599 INDIGO SYSTEM ASPIRATION CATHETER 8 QEW QEW PENUMBRA, INC. H00000100 00815948022324

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male