BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENCHMARK 6F 071 DELIVERY CATHETER

    MDR report key: 16962397 · Received May 19, 2023

    Report

    Report Number
    3005168196-2023-00233
    Event Type
    Malfunction
    Date Received
    May 19, 2023
    Date of Event
    April 21, 2023
    Report Date
    August 1, 2023
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    UDI-DI
    00814548014050
    PMA / PMN Number
    K142321
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTION WAS UPDATED ON THIS FOLLOW-UP #01 MFR REPORT: 3005168196-2023-00233: 1. SECTION B. BOX 5. DESCRIBE EVENT OR PROBLEM EVALUATION OF THE RETURNED BENCHMARK CONFIRMED A FRACTURE ON THE PROXIMAL END. EVALUATION ALSO REVEALED KINKS ON THE PROXIMAL END, AND AN OVALIZATION NEAR THE DISTAL TIP. IF THE DEVICE IS ADVANCED AGAINST RESISTANCE, DAMAGE SUCH AS KINKS MAY OCCUR. SUBSEQUENTLY, IF THE DEVICE IS RETRACTED AGAINST RESISTANCE, DAMAGE SUCH AS A FRACTURE MAY OCCUR. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS DIFFICULT TO ACCESS DUE TO ELONGATED VESSELS. THIS MAY HAVE CONTRIBUTED TO RESISTANCE DURING THE PROCEDURE AND THE OVALIZATION ON THE DISTAL END. PENUMBRA PRODUCTS ARE VISUALLY 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.

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT VERTEBRAL ARTERY USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY ADVANCING THE BENCHMARK OVER A GUIDEWIRE TO THE TARGET VESSEL DUE TO THE PATIENT¿S ANATOMY BEING DIFFICULT WITH ELONGATED VESSELS. AFTER SEVERAL ATTEMPTS, THE PHYSICIAN SUCCESSFULLY ADVANCED THE BENCHMARK OVER THE GUIDEWIRE TO THE TARGET VESSEL. AFTERWARDS, THE GUIDEWIRE WOULD NOT ROTATE SLIGHTLY AS EXPECTED. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE BENCHMARK AND GUIDEWIRE. WHILE REMOVING THE BENCHMARK, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY FRACTURED THE PROXIMAL END OF THE BENCHMARK OUTSIDE THE PATIENT. THE ENTIRE BENCHMARK WAS THEN PULLED OUT OF THE PATIENT BY HAND AND NO ADDITIONAL INTERVENTION WAS REQUIRED. THE PHYSICIAN WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT VERTEBRAL ARTERY USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY ADVANCING THE BENCHMARK OVER A GUIDEWIRE TO THE TARGET VESSEL DUE TO THE PATIENT¿S ANATOMY BEING DIFFICULT WITH ELONGATED VESSELS. AFTER SEVERAL ATTEMPTS, THE PHYSICIAN SUCCESSFULLY ADVANCED THE BENCHMARK OVER THE GUIDEWIRE TO THE TARGET VESSEL. AFTERWARDS, THE GUIDEWIRE WOULD NOT ROTATE SLIGHTLY AS EXPECTED. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE BENCHMARK AND GUIDEWIRE. WHILE REMOVING THE BENCHMARK, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY FRACTURED THE PROXIMAL END OF THE BENCHMARK. THE BENCHMARK WAS REMOVED AND NO LONGER USED IN THE PROCEDURE. THE PHYSICIAN WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478905 BENCHMARK 6F 071 DELIVERY CATHETER DQY DQY PENUMBRA, INC. F00003201 00814548014050

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Male