BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELOCITY DELIVERY MICROCATHETER

    MDR report key: 19434152 · Received May 31, 2024

    Report

    Report Number
    3005168196-2024-00214
    Event Type
    Malfunction
    Date Received
    May 31, 2024
    Date of Event
    May 12, 2024
    Report Date
    July 12, 2024
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    UDI-DI
    00814548012629
    PMA / PMN Number
    K100826
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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

    PLEASE NOTE THAT THE FOLLOWING SECTION WAS INCORRECTLY REPORTED ON THE INITIAL MFR REPORT AND IS BEING CORRECTED ON THIS FOLLOW-UP #01 MFR REPORT: 3005168196-2024-00214. 1. SECTION D. BOX 4. UNIQUE IDENTIFIER. EVALUATION OF THE RETURNED VELOCITY CONFIRMED THAT THE DEVICE WAS FRACTURED. IF THE VELOCITY IS ADVANCED AGAINST RESISTANCE DURING USE, DAMAGE SUCH AS A KINK AND SUBSEQUENT FRACTURE MAY OCCUR. THE REPORTED TORTUOUS PATIENT''S ANATOMY MAY HAVE CONTRIBUTED TO THE RESISTANCE DURING THE PROCEDURE. 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 · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A VELOCITY DELIVERY MICROCATHETER (VELOCITY), A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62), AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE VELOCITY THROUGH THE RED62, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE VELOCITY. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE PROXIMAL END OF THE VELOCITY WAS FRACTURED. THE PROCEDURE WAS COMPLETED USING A NEW VELOCITY AND THE SAME RED62. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229146 VELOCITY DELIVERY MICROCATHETER DQY DQY PENUMBRA, INC. F00003046 00814548012629

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male