BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 23441834 · Received October 31, 2025

    Report

    Report Number
    2242352-2025-0001171
    Event Type
    Malfunction
    Date Received
    October 31, 2025
    Date of Event
    October 9, 2025
    Report Date
    October 31, 2025
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700406
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). UPDATED SECTIONS: B4, G6, H2, H11. CORRECTED SECTIONS: G3 - IN THE MFG REPORT NUMBER. 2242352-2025-0001171, MFG FOLLOW-UP # 1 THE FIELD "DATE RECEIVED BY MFG" WAS INCORRECTLY CAPTURED I.E. 27-OCT-2025. THE CORRECT "DATE RECEIVED BY MFG" IS 10-DEC-2025.

    Additional Manufacturer Narrative · 0

    TW (B)(4). UPDATED SECTIONS: B3, B4, B5, G3, G6, H2, H3, H6, H11. THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 10/20/2025. AN INVESTIGATION WAS CONDUCTED ON 10/20/2025. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND NO EVIDENCE OF BLOOD WAS OBSERVED. THE CANNULA AND C-RING WERE OBSERVED TO BE INTACT. A MICROSCOPIC INSPECTION WAS CONDUCTED. THE ENDO LOOP HOLE IN THE END OF THE C-RING (METAL ROD SIDE) WAS VISIBLE. A NEEDLE WAS UTILIZED TO TEST THE FABRICATION AND DEPTH OF THE HOLE. IT WAS UNABLE TO BE PASSED THROUGH, BUT THE HOLE WAS OBSERVED TO BE OCCLUDED BY THE PLASTIC MATERIAL OF THE C-RING AND COULD NOT PASS ENTIRELY THROUGH. BASED ON THE RETURNED CONDITION OF THE DEVICE AND THE RESULTS OF THE EVALUATION, THE REPORTED FAILURE "MECHANICAL PROBLEM" WAS CONFIRMED. A MANUFACTURING ENGINEERING EVALUATION WAS CONDUCTED. THE COMPLAINT WAS CONFIRMED FOR THE REPORTED FAILURE OF "MECHANICAL PROBLEM". A VISUAL EVALUATION WAS PERFORMED. THERE WERE SIGNS OF CLINICAL USE. THE CANNULA AND C-RING WERE OBSERVED TO BE INTACT. A MICROSCOPIC INSPECTION WAS CONDUCTED. THE ENDO LOOP HOLE IN THE END OF THE C-RING (METAL ROD SIDE) WAS VISIBLE. A SUTURE WAS UTILIZED TO TEST THE ENDO LOOP HOLE. IT WAS UNABLE TO BE PASSED THROUGH. UPON CLOSER INVESTIGATION IT WAS OBSERVED THAT THE ENDO LOOP HOLE ON THE C-RING WAS OCCLUDED WITH ADHESIVE. OUT OF TOLERANCE CONSIDERATION: ADHESIVE IS APPLIED TO THE C-RING MOLDED NOZZLE HOLE, THE C-RING MAIN WIRE IS SUBSEQUENTLY PLACED IN THE C-RING HOLE AND CURED PER WORK INSTRUCTION MCV00015995 (C-RING BONDING, TUBE WITH RIB). THE SHOP FLOOR PAPERWORK FOR THE EVH CANNULA SUBASSEMBLY BATCHES 3000498939 AND 3000499227 (MATERIAL NUMBER CV000011318) WAS REVIEWED TO IDENTIFY THE EQUIPMENT USED AT THE C-RING BONDING STATION. SUBSEQUENTLY, AN OOT QUERY WAS PERFORMED FOR THE DATE RANGE FROM 01-OCT-2023 TO 09-OCT-2025. AN ANALYSIS WAS PERFORMED, WHICH CONFIRMED THAT NO EQUIPMENT USED IN THE C-RING BONDING PROCESS (WORK INSTRUCTION MCV00015995) WAS OUT OF TOLERANCE. BASED ON THE RETURNED CONDITON OF THE DEVICE AS WELL AS THE MANUFACTURING ENGINEERING EVALUATION, THE REPORTED FAILURE "MECHANICAL PROBLEM" WAS CONFIRMED. THE LOT # 3000499920 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT THEY USE THE VASOVIEW HEMOPRO 2 HOLE THAT IS IN THE C RING AS A KNOT PUSHER FOR THE ENDOLOOP. THEY USE IT TO PUSH UP THE TUNNEL TO TIE OFF THE CONDUIT. THIS DEVICE DOES NOT HAVE THE HOLE CUT INTO THE C RING. THERE WAS ONLY A DELAY TO GRAB A NEW DEVICE. THE ACCOUNT OPENED A NEW DEVICE AND COMPLETED THE PROCEDURE AS USUAL. THE PATIENT WAS IN THE ROOM BUT THERE WAS NO PATIENT EFFECT.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT THEY USE THE HOLE THAT IS IN THE C RING AS A KNOT PUSHER FOR THE ENDOLOOP. THEY USE IT TO PUSH UP THE TUNNEL TO TIE OFF THE CONDUIT. THIS DEVICE DOES NOT HAVE THE HOLE CUT INTO THE C RING. THE DEVICE WILL BE RETURNED FOR INSPECTION. THERE WAS ONLY A DELAY TO GRAB A NEW DEVICE. THE ACCOUNT OPENED A NEW DEVICE AND COMPLETED THE PROCEDURE AS USUAL. THE PATIENT WAS IN THE ROOM BUT THERE WAS NO PATIENT EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1894291 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VH-4000 3000499920 00607567700406

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN.