BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 24219900 · Received January 30, 2026

    Report

    Report Number
    2242352-2026-0000033
    Event Type
    Malfunction
    Date Received
    January 30, 2026
    Date of Event
    January 6, 2026
    Report Date
    January 30, 2026
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700406
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    TW (B)(4) UPDATED FIELDS: B4, G3, G6, H2, H3, H6, H11. THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 01/28/2026. AN INVESTIGATION WAS CONDUCTED ON 01/29/2026. BTT WAS RETURNED FOR EVALUATION. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WAS OBSERVED. THERE WERE NO VISUAL DEFECTS OBSERVED ON THE INTACT BTT. A 25 CC SYRINGE, FILLED WITH AIR WAS ATTACHED TO THE INFLATION PORT LINE ON THE BTT AND SQUEEZED THE SYRINGE TO INJECT AIR. THE BTT WAS NOT ABLE TO BE INFLATED DUE TO DAMAGE NOTED ON THE BALLOON OF THE BTT. A 25CC SYRINGE, FILLED WITH SALINE WAS ATTACHED TO THE CO2 LINE ON THE BTT AND SQUEEZED THE SYRINGE TO SPRAY AND A WHOLE WAS OBSERVED IN THE BALLOON. BASED ON THE RETURNED CONDITION OF THE DEVICE AS WELL AS THE EVALUATION RESULTS, THE REPORTED FAILURE "INFLATION PROBLEM" WAS CONFIRMED. A MANUFACTURING ENGINEERING EVALUATION WAS CONDUCTED. THE COMPLAINT WAS CONFIRMED FOR DAMAGE NOTED ON THE BALLOON OF THE BTT ASSEMBLY (CUT ON THE BTT BALLOON NOTED). DETAILS OF THE INVESTIGATION CONDUCTED IS NOTED AS FOLLOWS: PRELIMINARY SCREENING INVESTIGATION: VISUAL INSPECTION OF THE DEVICE FOR USE: THE BTT ASSEMBLY WAS VISUALLY INSPECTED FOR USE AND WAS NOTED TO BE LIGHTLY COVERED WITH DRIED BLOOD AND TISSUE, CONFIRMING IT TO HAVE BEEN USED WITHIN THE PROCEDURE. VISUAL INSPECTION OF THE BALLOON FOR TEARS, PINHOLES, AND OTHER DAMAGE: THE BALLOON OF THE BTT WAS INSPECTED AND A CUT WAS NOTED IN THE MIDDLE OF THE BALLOON. IN REVIEW OF THE LOCATION OF THE CUT, THE CUT WAS IN THE MIDDLE OF THE BTT BALLOON AND NOT ON THE EDGES OF THE PROXIMAL OR DISTAL SUTURE LINES. EVERY MANUFACTURED BTT SUBASSEMBLY IS SUBJECTED TO THE 50CC INFLATION TEST PER MCV00009036 REV M. IF THE CUT WAS PRESENT DURING MANUFACTURING THE BTT SUBASSEMBLY WOULD HAVE FAILED THE 50CC INFLATION TEST. THIS INDICATES THAT THE CUT ON THE BALLOON WAS GENERATED DURING THE COURSE OF THE PROCEDURE. THE LOT # 3000512805 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.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING A CABG PROCEDURE, THE CUSTOMER INTENDED TO USE THE VASOVIEW HEMOPRO 2 FOR VESSEL HARVESTING. IT WAS FOUND THAT THE BTT CUFF COULD NOT BE INFLATED. THE ENTIRE BOX WAS COLLECTED AND EXCHANGED FOR A NEW ONE. NO DELAY. THERE WAS NO HARM TO THE PATIENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596911 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VH-4000 3000512805 00607567700406

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NO CONCOMITANT PRODUCTS WERE USED.