BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELOCITY DELIVERY MICROCATHETER

    MDR report key: 19203482 · Received April 29, 2024

    Report

    Report Number
    3005168196-2024-00164
    Event Type
    Malfunction
    Date Received
    April 29, 2024
    Report Date
    June 27, 2024
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    UDI-DI
    00814548012629
    PMA / PMN Number
    K100826
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    PLEASE NOTE THAT THE FOLLOWING SECTIONS WERE INCORRECTLY REPORTED ON THE INITIAL MFR REPORT AND ARE BEING CORRECTED ON THIS FOLLOW-UP # 1 MFR REPORT: 3005168196-2024-00164. 1. SECTION D. BOX 4. UNIQUE IDENTIFIER. 2. SECTION E. BOX 4. INITIAL REPORTER ALSO SENT REPORT TO FDA. EVALUATION OF THE RETURNED VELOCITY CONFIRMED A FRACTURE ON THE PROXIMAL END. FURTHER EVALUATION REVEALED THAT THE INTERNAL COIL WINDS WERE UNRAVELING AT THE FRACTURED LOCATION. IT WAS REPORTED THAT RESISTANCE WAS EXPERIENCED, AND THE STENT RETRIEVER BECAME STUCK WHILE ADVANCING THROUGH THE RETURNED VELOCITY; THIS MAY HAVE CAUSED SOME DAMAGE TO THE INTERNAL LINER, EXPOSING THE COIL WINDS. SUBSEQUENTLY, IF THE DEVICE IS RETRACTED AT AN ANGLE, DAMAGE SUCH AS A FRACTURE MAY OCCUR. 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 INTERNAL CAROTID ARTERY (ICA) TERMINUS USING A VELOCITY DELIVERY MICROCATHETER (VELOCITY), A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68), A NON-PENUMBRA SHEATH, A NON-PENUMBRA GUIDE CATHETER, STENT RETRIEVERS, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN POSITIONED THE VELOCITY IN THE TARGET LOCATION. WHILE ATTEMPTING TO ADVANCE A STENT RETRIEVER THROUGH THE VELOCITY, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE STENT RETRIEVER BECAME STUCK AT THE PROXIMAL END OF THE VELOCITY. THE STENT RETRIEVER WAS THEN REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW STENT RETRIEVER THROUGH VELOCITY; HOWEVER, THE SAME ISSUE OCCURRED. WHILE ATTEMPTING TO REMOVE THE VELOCITY, THE PHYSICIAN FRACTURED THE VELOCITY AT THE PROXIMAL END. THE PHYSICIAN THEN RETRACTED THE PROXIMAL SEGMENT OF THE VELOCITY, INITIATED ASPIRATION AND USED THE RED68 TO SUCCESSFULLY REMOVE THE SYSTEM ALONG WITH THE DISTAL SEGMENT OF THE VELOCITY. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER, THE SAME RED68, STENT RETRIEVER, SHEATH, AND GUIDEWIRE. THE EXACT EVENT DATE IS UNKNOWN.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) TERMINUS USING A VELOCITY DELIVERY MICROCATHETER (VELOCITY), A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68), A NON-PENUMBRA SHEATH, A NON-PENUMBRA GUIDE CATHETER, STENT RETRIEVERS, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN POSITIONED THE VELOCITY IN THE TARGET LOCATION. WHILE ATTEMPTING TO ADVANCE A STENT RETRIEVER THROUGH THE VELOCITY, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE STENT RETRIEVER BECAME STUCK AT THE PROXIMAL END OF THE VELOCITY. THE STENT RETRIEVER WAS THEN REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW STENT RETRIEVER THROUGH VELOCITY; HOWEVER, THE SAME ISSUE OCCURRED. WHILE ATTEMPTING TO REMOVE THE VELOCITY, THE PHYSICIAN FRACTURED THE VELOCITY AT THE PROXIMAL END. THE PHYSICIAN THEN RETRACTED THE PROXIMAL SEGMENT OF THE VELOCITY, INITIATED ASPIRATION AND USED THE RED68 TO SUCCESSFULLY REMOVE THE SYSTEM ALONG WITH THE DISTAL SEGMENT OF THE VELOCITY. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER, THE SAME RED68, STENT RETRIEVER, SHEATH, AND GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. THE EXACT EVENT DATE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980243 VELOCITY DELIVERY MICROCATHETER DQY DQY PENUMBRA, INC. F00007778 00814548012629

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male