BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 22932136 · Received September 2, 2025

    Report

    Report Number
    2242352-2025-0001012
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    August 8, 2025
    Report Date
    August 28, 2025
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700406
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TW # (B)(4). UPDATED SECTIONS: B4,D9,G3,G6,H2,H3,H6,H11. THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 09/10/2025. AN INVESTIGATION WAS CONDUCTED ON 09/11/2025. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WAS OBSERVED. A 25 CC SYRINGE, FILLED WITH AIR WAS ATTACHED TO THE INFLATION PORT LINE ON THE BTT. THE SYRINGE PLUNGER WAS DEPRESSED TO INJECT AIR. THE BTT WAS UNABLE TO BE INFLATED. A 5CC SYRINGE, FILLED WITH SALINE WAS ATTACHED TO THE CO2 LINE ON THE BTT AND SQUEEZED THE SYRINGE TO SPRAY THE SALINE. THERE WAS NO BACKFLOW OBSERVED IN THE CO2 LINE. BASED ON THE CONDITION OF THE DEVICE, THE REPORTED FAILURE "NO FLOW" WAS NOT CONFIRMED, HOWEVER, THE ANALYZED FAILURE "INFLATION PROBLEM". A MANUFACTURING ENGINEERING EVALUATION WAS CONDUCTED. PRELIMINARY SCREENING INVESTIGATION: VISUAL INSPECTION OF THE DEVICE FOR USE: THE BTT ASSEMBLY 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. THE REPORTED FAILURE OF "IMPROPER FLOW OR INFUSION" WAS NOT CONFIRMED. A 5CC SYRINGE, FILLED WITH SALINE WAS ATTACHED TO THE CO2 LINE ON THE BTT AND THE PLUNGER WAS DEPRESSED TO DELIVER THE SALINE. THERE WAS NO BACKFLOW OBSERVED IN THE CO2 LINE. A 25 CC SYRINGE, FILLED WITH AIR WAS ATTACHED TO THE INFLATION PORT LINE ON THE BTT. THE SYRINGE PLUNGER WAS DEPRESSED TO INJECT AIR. THE BTT WAS UNABLE TO BE INFLATED. THE COMPLAINT WAS CONFIRMED FOR THE AS ANALYZED FAILURE MODE "INFLATION PROBLEM" DUE TO DAMAGE NOTED ON THE BALLOON OF THE BTT ASSEMBLY (RUPTURE ON BTT BALLOON NOTED). VISUAL INSPECTION OF THE BALLOON FOR TEARS, PINHOLES, AND OTHER DAMAGE: THE BALLOON OF THE BTT WAS INSPECTED, AND, A RUPTURE WAS NOTED ON THE BALLOON ALONG THE SUTURE LINE OF THE PART. AS A FOLLOW UP TO THE INVESTIGATION PERFORMED AT THE WAYNE FACILITY, THE BTT COMPLAINT UNIT WAS SENT TO THE ATRIUM FACILITY IN MERRIMACK, NEW HAMPSHIRE TO ASSESS THE POTENTIAL CAUSE OF THE RUPTURE. THE COMPLAINT UNIT WAS ASSESSED THROUGH OPTICAL MICROSCOPY, SEM/EDS, FTIR, AND DSC. BASED ON THE INSPECTIONS AND INFORMATION PROVIDED, THE RUPTURE OF THE BTT BALLOON APPEARS TO HAVE STARTED FROM A SMALL SMOOTH CUT WITH NO JAGGED EDGES WHICH EXISTED ALONG THE EDGE OF THE BALLOON. WHEN THE BALLOON WAS INFLATED, THE CUT THEN EXPANDED FURTHER IN BOTH LENGTH AND DEPTH INTO THE BALLOON LAYER, EVENTUALLY PENETRATING THE FULL THICKNESS OF THE BALLOON, RESULTING IN THE BALLOON NO LONGER BEING ABLE TO RETAIN AIR. RELATING TO THE ORIGIN OF THE SMALL CUT NOTED ON THE BTT, A REVIEW OF THE ASSEMBLY PROCESS WAS CONDUCTED, LOOKING AT POTENTIAL AREAS FOR A SMALL CUT SUCH AS THIS TO HAVE POSSIBLY OCCURRED. IN REVIEW OF THE LOCATION OF THE CUT, THIS LOCATION ALIGNS WITH THE TYPICAL PLACEMENT OF THE EYELET SUTURE USED FOR TYING OF THE SUTURE FOLLOWING WINDING. BASED ON THIS REVIEW, IT APPEARS THAT THE SMALL CUT ON THE BALLON MAY HAVE BEEN INTRODUCED DURING THE REMOVAL OF THE EYELET FROM THE BALLOON DURING MANUFACTURING. THE LOT # 3000471463 HISTORY RECORD REVIEW WAS COMPLETED. THERE WAS AN NCMR 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 OR THE ANALYZED FAILURE.

    Additional Manufacturer Narrative · 0

    (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.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED HEMOPRO II WAS PREPARED FOR SAPHENOUS VEIN HARVESTING. AIR LEAKAGE FROM THE BTT PORT WAS DETECTED DURING PORT INSERTION PREPARATION. THE TUBING WAS PROPERLY CONNECTED AND 4.5L OF AIR WAS DELIVERED, APPROPRIATE ACCORDING TO THE INSTRUCTION MANUAL. THIS WAS RESOLVED BY USING A NEW DEVICE. THERE WAS NO PROCEDURAL DELAY. NO ADVERSE HEALTH EFFECTS WERE OBSERVED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2214447 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VH-4000 3000471463 00607567700406

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown