BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELOCITY DELIVERY MICROCATHETER

    MDR report key: 16737256 · Received April 13, 2023

    Report

    Report Number
    3005168196-2023-00167
    Event Type
    Malfunction
    Date Received
    April 13, 2023
    Date of Event
    March 19, 2023
    Report Date
    May 9, 2023
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    UDI-DI
    00814548012629
    PMA / PMN Number
    K100826
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION RESULTS ARE PENDING. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 3005168196-2023-00168.

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTION WAS UPDATED ON THIS FOLLOW-UP #01 MFR REPORT 3005168196-2023-00167 1. SECTION B. BOX 5. DESCRIBE EVENT OR PROBLEM. EVALUATION OF THE FIRST RETURNED VELOCITY CONFIRMED THAT THE CATHETER WAS FRACTURED. IF THE VELOCITY IS MANIPULATED AGAINST RESISTANCE DURING USE, DAMAGE SUCH AS A KINK AND SUBSEQUENT FRACTURE MAY OCCUR. BASED ON THE REPORTED COMPLAINT, THE ROOT CAUSE OF RESISTANCE DURING THE PROCEDURE COULD NOT BE DETERMINED. 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 TO TREAT A BASILAR OCCLUSION USING A VELOCITY DELIVERY MICROCATHETER (VELOCITY), PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68), NON-PENUMBRA SHEATH, AND A NON-PENUMBRA GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING THE RED68 CONTAINING THE VELOCITY AND GUIDEWIRE TO THE CLOT, THE PHYSICIAN WAS PULLING BACK ON THE VELOCITY TO BE REMOVED AND NOTED PRESSURE ON THE VELOCITY. SUBSEQUENTLY, THE SHEATH CONTAINING THE RED68, VELOCITY, AND GUIDEWIRE WAS REMOVED. THE VELOCITY WAS THEN REMOVED OUT FROM THE RED68, AND THE DISTAL END OF THE VELOCITY WAS BROKEN INTO TWO PIECES. THEREFORE, THE VELOCITY WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. NEXT, THE PHYSICIAN ADVANCED A NEW VELOCITY; HOWEVER, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO REMOVE THE VELOCITY. UPON REMOVAL, THE DISTAL END OF THE VELOCITY HAD FRACTURED. THEREFORE, THE VELOCITY WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW VELOCITY WITH THE SAME RED68 AND SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A BASILAR OCCLUSION USING A VELOCITY DELIVERY MICROCATHETER (VELOCITY), PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68), NON-PENUMBRA SHEATH, AND A NON-PENUMBRA GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING THE RED68 CONTAINING THE VELOCITY AND GUIDEWIRE TO THE CLOT, THE PHYSICIAN WAS PULLING BACK ON THE VELOCITY TO BE REMOVED AND NOTED RESISTANCE ON THE VELOCITY. SUBSEQUENTLY, THE SHEATH CONTAINING THE RED68, VELOCITY, AND GUIDEWIRE WAS REMOVED. THE VELOCITY WAS THEN REMOVED OUT FROM THE RED68, AND THE DISTAL END OF THE VELOCITY WAS BROKEN INTO TWO PIECES. THEREFORE, THE VELOCITY WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. NEXT, THE PHYSICIAN ADVANCED A NEW VELOCITY; HOWEVER, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO REMOVE THE VELOCITY. UPON REMOVAL, THE DISTAL END OF THE VELOCITY WAS NOTICED TO BE KINKED. THEREFORE, THE VELOCITY WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW VELOCITY WITH THE SAME RED68 AND SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1137546 VELOCITY DELIVERY MICROCATHETER DQY DQY PENUMBRA, INC. F00001415 00814548012629

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male