BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 20138178 · Received September 4, 2024

    Report

    Report Number
    2242352-2024-01003
    Event Type
    Injury
    Date Received
    September 4, 2024
    Date of Event
    August 14, 2024
    Report Date
    October 21, 2024
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700406
    PMA / PMN Number
    K101274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TW ID#(B)(4). THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.

    Additional Manufacturer Narrative · 0

    TW # (B)(4). THE DEVICE WAS NOT RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION; HOWEVER, PHOTOGRAPHS WERE PROVIDED BY THE ACCOUNT. A PHOTOGRAPHIC EVALUATION WAS CONDUCTED. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WAS OBSERVED. THE SCOPE WASH TUBE WAS OBSERVED TO BE TRANSECTED AND MELTED CLOSER TO THE BASE OF THE C-RING. THE C-RING WAS ALSO OBSERVED TO BE TRANSECTED AND MELTED DOWN THE CENTER OF THE C-RING, NO OTHER VISUAL DEFECTS WERE OBSERVED. BASED ON THE NON-RETURN OF THE DEVICE AS WELL AS THE PHOTOGRAPHIC EVALUATION, THE REPORTED FAILURE "BREAK-C-RING" WAS CONFIRMED. THE LOT # 3000410102 HISTORY RECORD REVIEW WAS COMPLETED. THERE WERE NO NCMRS, REWORK, OR DEVIATIONS DOCUMENTED FOR THE REPORTED LOT NUMBER. BASED ON THE DHR/LHR REVIEW RESULTS, IT WAS DETERMINED THAT THERE IS NO RELATION BETWEEN THE BATCH MANUFACTURING PROCESS AND THE REPORTED FAILURE. SPECIFIC ACTIONS FOR THE REPORTED FAILURE MODE ARE BEING MAINTAINED AND DOCUMENTED UNDER MAQUET'S CORRECTIVE AND PREVENTIVE ACTION (CAPA) SYSTEM.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE HEMOPRO 2 (VH-4000) TIP BROKE (CRADLE-C-RING BROKE) WHILE HARVESTING. THE HARVESTER WAS ABLE TO REMOVE THE PIECE BY MAKING A SMALL INCISION AND GRABBING IT WITH A PAIR OF HEMOSTATS. THE JAWS OF THERE HARVESTING TOOL WERE NOT OPEN, AND NO RESISTANCE WAS NOTED WHILE INSERTING THE HARVESTING TOOL INTO THE CANNULA. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PROCEDURAL DELAYS OR HARM/EFFECTS TO PATIENT. PHOTOS PROVIDED BY THE COMPLAINANT SHOW THE C-RING WITH EVIDENCE OF BLOOD BROKEN OFF THE DEVICE.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1237411 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VH-4000 3000410102 00607567700406

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention UNKNOWN.