BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BENCHMARK 6F 071 DELIVERY CATHETER

    MDR report key: 12785162 · Received November 10, 2021

    Report

    Report Number
    3005168196-2021-02521
    Event Type
    Injury
    Date Received
    November 10, 2021
    Date of Event
    October 14, 2021
    Report Date
    August 22, 2022
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    UDI-DI
    00814548014128
    PMA / PMN Number
    K142321
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTION IS BEING UPDATED BASED ON ADDITIONAL INFORMATION RECEIVED FROM THE DEVICE RETURN: 1. SECTION B. BOX 5. DESCRIBE EVENT OR PROBLEM. EVALUATION OF THE RETURNED BENCHMARK CONFIRMED THE DEVICE WAS FRACTURED ON ITS PROXIMAL SHAFT. THIS DAMAGE TYPICALLY OCCURS IF THE DEVICE IS FORCEFULLY RETRACTED AGAINST RESISTANCE. EVALUATION OF THE NON-PENUMBRA SHORT SHEATH REVEALED A TEAR ALONG THE LENGTH OF THE DEVICE STARTING ON THE DISTAL END. THE CAUSE OF THIS DAMAGE COULD NOT BE DETERMINED. THIS DAMAGE MAY HAVE CONTRIBUTED TO RESISTANCE DURING RETRACTION OF THE BENCHMARK AND MAY HAVE CONTRIBUTED TO THE BENCHMARK BECOMING FRACTURED. EVALUATION ALSO REVEALED DAMAGE NEAR THE FRACTURE AND UNRAVELED INTERNAL COIL WINDS. THIS DAMAGE LIKELY OCCURRED DURING SNARING ATTEMPTS TO RETRIEVE THE BENCHMARK. FURTHER EVALUATION REVEALED ADDITIONAL KINKS ALONG THE DEVICE. THIS DAMAGE WAS LIKELY INCIDENTAL TO THE REPORTED COMPLAINT. 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.

    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

    C53588} WAS INADVERTENTLY LEFT OFF OF THE FOLLOW-UP #01 AND IS BEING ADDED ON THIS FOLLOW-UP #02 MFR REPORT: H3 OTHER TEXT : PLACEHOLDER.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A NON-PENUMBRA SHORT SHEATH, A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NON-PENUMBRA MICROCATHETER AND PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THE SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER AND BENCHMARK. SUBSEQUENTLY, WHILE REMOVING THE BENCHMARK, A PIECE OF THE BENCHMARK BROKE OFF IN THE VESSEL. THEREFORE, THE PHYSICIAN DECIDED TO USE A SNARE DEVICE TO RETRIEVE THE BROKEN PIECE. WHILE REMOVING THE BROKEN PIECE OF THE BENCHMARK USING THE SNARE DEVICE, THE FEMORAL ARTERY BECAME DAMAGED. SUBSEQUENTLY, THE PATIENT UNDERWENT A VASCULAR REPAIR OF THE GROIN PUNCTURE SITE. THE PROCEDURE ENDED AFTER THE SUCCESSFUL VASCULAR REPAIR.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THE SMART COILS IN THE TARGET VESSEL USING THE PX SLIM AND BENCHMARK. SUBSEQUENTLY, WHILE REMOVING THE BENCHMARK, A PIECE OF THE BENCHMARK BROKE OFF IN THE VESSEL. THEREFORE, THE PHYSICIAN DECIDED TO USE A SNARE DEVICE TO RETRIEVE THE BROKEN PIECE. WHILE REMOVING THE BROKEN PIECE OF THE BENCHMARK USING THE SNARE DEVICE, THE FEMORAL ARTERY BECAME DAMAGED. SUBSEQUENTLY, THE PATIENT UNDERWENT A VASCULAR REPAIR OF THE GROIN PUNCTURE SITE. THE PROCEDURE ENDED AFTER THE SUCCESSFUL VASCULAR REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1684852 BENCHMARK 6F 071 DELIVERY CATHETER DQY DQY PENUMBRA, INC. BMK6F95BER120 F107915 00814548014128

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention