BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMPRO 3

    MDR report key: 22909828 · Received August 27, 2025

    Report

    Report Number
    2242352-2025-0000985
    Event Type
    Malfunction
    Date Received
    August 27, 2025
    Date of Event
    July 31, 2025
    Report Date
    November 20, 2025
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567701274
    PMA / PMN Number
    K251238
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TW # (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

    (B)(4). UPDATED SECTIONS: B4, G3, G6, H2, H3, H6, H11. THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 08/14/2025. ENGINEER EVALUATION FOLLOWS: THE COMPLAINT WAS CONFIRMED FOR DAMAGE NOTED ON THE BALLOON OF THE BTT ASSEMBLY (RUPTURE ON BTT BALLOON NOTED). DETAILS OF THE INVESTIGATION CONDUCTED IS NOTED AS FOLLOWS: PRELIMINARY SCREENING INVESTIGATION OF ASSEMBLY FEATURES: 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. VISUAL INSPECTION OF THE CHECK VALVE STEM FOR ALIGNMENT OR DAMAGE: THE CHECK VALVE STEM WAS INSPECTED AND APPEARED UNDAMAGED, PROPERLY ALIGNED AND SEATED, WITH THE INNER SEPTUM SEAL IN TACT. NO EVIDENCE OF DAMAGE OR NON-CONFORMANCE. VISUAL INSPECTION OF THE LUER FITTING FOR DAMAGE: THE LUER FITTING AND CONNECTED TUBING WAS INSPECTED AND APPEARED TO BE IN-TACT AND UNDAMAGED, WITH THE SEPTUM PORT NOTED TO BE IN-TACT. NO EVIDENCE OF DAMAGE OR NONCONFORMANCE VISUAL INSPECTION OF THE INSUFFLATION PATH FOR BLOCKAGES OR ADHESIVE MIGRATION: THE INNER BARREL OF THE BTT WAS INSPECTED AND APPEARED UNDAMAGED, WITH THE INSUFFLATION PATH APPEARING CLEAR WITH NO OBSTRUCTIONS WHICH WOULD HAVE PREVENTED IT FROM TUNNEL INSUFFLATION. NO NON-CONFORMANCE'S NOTED. VISUAL INSPECTION OF INNER LUMEN FOR ADHESIVE MIGRATION OR OTHER DEFECTS: THE INNER LUMEN OF THE BTT WAS INSPECTED AND APPEARED UNDAMAGED WITH NO OBSTRUCTIONS NOTED. IN ADDITION, THE ADHESIVE WHICH IS PLACED ONTO THE OPEN END OF THE BALLOON INFLATION PORT WAS IN PLACE AND SHOWED NO SIGNS OF MIGRATION. NO NON-CONFORMANCE'S NOTED. VISUAL INSPECTION OF THE CANNULA AND ENDOSCOPE SEALS: ONLY THE CANNULA SEAL WAS RECEIVED BACK WITH THE BTT ASSEMBLY, NOT THE ENDOSCOPE SEAL. WITHIN THE COMPLAINT DESCRIPTION, IT WAS NOTED THAT THE USER WAS ABLE TO COMPLETE THE ENDOSCOPIC DISSECTION WITHOUT INCIDENT. BASED ON THE INFORMATION GATHERED, THERE WERE NO NOTED ISSUES WITH THE ENDOSCOPE SEAL DURING APPLICATION. THE BTT CANNULA SEAL WAS INSPECTED, SHOWING IT TO BE IN-TACT WITH NO EVIDENCE OF DAMAGE OR ANOMALIES WHICH WOULD HAVE PREVENTED IT FROM MAKING A SEAL BETWEEN THE CANNULA AND THE BTT BODY. NO NONCONFORMANCE'S 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. BTT BALLOON RUPTURE INSPECTION: AN INSPECTION WAS PERFORMED LOOKING AT THE RUPTURE NOTED ON THE BALLOON OF THE ASSEMBLY. THE LINE OF THE RUPTURE WAS NOTED TO BE APPROXIMATELY A QUARTER OF THE CIRCUMFERENCE OF THE BALLOON, AND, THE VISUAL PROFILE OF THE RUPTURE APPEARED TO LOOK LIKE A TEAR RUNNING NEARLY PARALLEL TO THE SUTURE LINE OF THE BTT. THE PERIMETER OF THE RUPTURE LINE WAS INSPECTED UNDER MAGNIFICATION FOR EVIDENCE OF A PROPAGATION POINT, AND, A SMALL NICK (CUT) WAS NOTED ALONG THE SURFACE OF ONE OF THE EDGES OF THE RUPTURE. WITHIN THE SCOPE OF THE COMPLAINT RECEIVED, IT WAS NOTED THAT THE BTT FUNCTIONED AS INTENDED UNTIL CLOSE TO THE CONCLUSION OF THE VESSEL TRANSECTION PORTION OF THE PROCEDURE. THIS PROVIDES FURTHER EVIDENCE THAT UPON INITIAL USE OF THE BTT, THE RUPTURE HAD NOT FULLY FORMED THROUGH THE FULL LAYER OF THE BTT BALLOON, AND IT WAS NOT UNTIL LATER IN THE PROCEDURE THAT THE RUPTURE HAD PENETRATED THE FULL THICKNESS OF THE BALLOON, RESULTING IN DEFLATION OF THE BTT. IN ADDITION, IT WAS NOTED WITHIN THE COMPLAINT SUMMARY THAT PRIOR TO THE BTT BALLOON DEFLATING, THE ASSEMBLY WAS INFLATED OVER THE SPECIFIED VOLUME WITHIN THE PRODUCT INSTRUCTIONS FOR USE (THE INSTRUCTIONS FOR USE SPECIFY THE BTT BALLOON TO BE INFLATED WITH 25 CUBIC CENTIMETERS (CC) OF AIR, WHERE, IT WAS NOTED THAT THE USER HAD USED THE FULL VOLUME OF THE 30CC SYRINGE). AS A FOLLOW UP TO THE INVESTIGATION PERFORMED AT THE WAYNE FACILITY, THE BTT COMPLAINT UNIT WAS SENT ALONG WITH A CONTROL UNIT (CONTROL UNIT TAKEN FROM HEMOPRO 3 PRODUCTION BATCH: 3000487231) TO THE ATRIUM FACILITY IN MERRIMACK, NEW HAMPSHIRE TO ASSESS WHETHER THERE WERE POTENTIAL DIFFERENCES IN THE PHYSICAL MAKEUP OF THE COMPLAINT UNIT AS WELL AS ASSESS THE POTENTIAL CAUSE OF THE RUPTURE. THE COMPLAINT AND CONTROL UNITS WERE ASSESSED THROUGH OPTICAL MICROSCOPY, SEM/EDS, AFM, FTIR, AND RAMAN SPECTROSCOPY, WHICH IS SUMMARIZED IN ATTACHMENT 1 OF THIS MEMO. THE RESULTS OF THE EVALUATION PERFORMED BY THE MERRIMACK SITE HAD SHOWN THE FOLLOWING: MICROSCOPIC AND SEM IMAGES INDICATED THAT THE TEAR ORIGINATED FROM WHAT APPEARS TO BE A MICRO-DEFECT OR NICK. THE DAMAGE THEN PROGRESSED INTO A DEEPER CUT, LIKELY DUE TO OVERSTRESSING OR THE APPLICATION OF ADDITIONAL EXTERNAL FORCE. NO CRACKS OR TEARS WERE OBSERVED ON THE CONTROL BALLOON; HOWEVER, SURFACE SCRATCHES WERE PRESENT. PARTICLES WERE OBSERVED ON THE SURFACE OF THE COMPLAINT AND CONTROL BALLOON. EDS ANALYSIS CONFIRMED THAT THE PARTICLES WHERE CONSISTENT WITH THE BALLOON MATERIAL, AS THE ELEMENTS DETECTED WERE CARBON, NITROGEN, OXYGEN AND SILICON. HOWEVER, POTASSIUM WAS ALSO DETECTED IN THE CONTROL BALLOON WHICH WAS NOT DETECTED IN THE COMPLAINT BALLOON. AFM ANALYSIS SHOWED NO DIFFERENCES IN TOPOGRAPHY, HOWEVER IN THE PHASE PROFILE THE COMPLAINT BALLOON SHOWED GREATER STRETCHING COMPARED TO THE CONTROL BALLOON, DUE TO BALLOON EXPANSION. FTIR AND RAMAN SPECTROSCOPY SHOWED NO DIFFERENCE IN THE IR SPECTRA AND RAMAN SHIFT BETWEEN THE COMPLAINT AND CONTROL BALLOON AND THE LIBRARY SEARCH CONFIRMED THAT THE MATERIAL IS SILICONE. IN SUMMARY, THE RESULTS SHOW NO DIFFERENCE IN THE MATERIAL BETWEEN THE COMPLAINT AND CONTROL BALLOON AND THAT THE RUPTURE OF THE BALLOON WAS STRESS-INDUCED WHICH INITIATED AT THE MICRO-DEFECT ON THE BALLOON POSSIBLE DUE TO THE NICK. BASED ON THE INSPECTIONS AND INFORMATION PROVIDED, THE RUPTURE OF THE BTT BALLOON APPEARS TO HAVE STARTED FROM A SMALL CUT WHICH EXISTED ALONG THE EDGE OF THE BALLOON. WHEN THE BALLOON WAS OVER 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 NICK/CUT ON THE BALLON MAY HAVE BEEN INTRODUCED DURING THE REMOVAL OF THE EYELET FROM THE BALLOON DURING MANUFACTURING. CONCLUSION: THE ROOT CAUSE OF THE FAILURE MODE "BURST CONTAINER OR VESSEL]" WAS DETERMINED TO BE DUE TO A MANUFACTURING DEFECT IN THE FORM OF A SMALL NICK/CUT ALONG THE EDGE OF THE SUTURE LINE OF BTT BALLOON, IN ADDITION TO OVER-STRESSING OF THE BALLOON DUE TO OVER-INFLATION PAST THE SPECIFIED 25ML. THE INTRODUCTION OF THE NICK/CUT APPEARS TO HAVE RESULTED DUE TO DAMAGE BEING IMPARTED ONTO THE BALLOON DURING REMOVAL OF THE SUTURE EYELET FOLLOWING THE SUTURE WINDING PROCESS OF THE BTT BALLOON. THE FAILURE IS THEREFORE NOTED TO HAVE COME FROM A COMBINATION OF A MANUFACTURING DEFECT ALONG WITH USE ERROR THROUGH OVER INFLATION. THE LOT#: 3000487726 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 DURING A CABG X2 AND VSD REPAIR, THAT THE HEMOPRO 3 BLUNT TIP TROCAR (BTT) BALLOON POPPED. THE HARVESTER WAS PERFORMING AND EVH ON THE PATIENTS LEFT UPPER LEG. THE INCISION WAS ROUGHLY 3 CM IN LENGTH ABOVE THE KNEE SINCE ONLY 1 LENGTH OF VEIN WAS NEEDED. PATIENT WAS VERY THIN WITH VERY ENLARGED KNOBBY KNEES IN WHICH THE HARVESTER ADMITTEDLY STRUGGLED TO NAVIGATE AROUND THE KNEES. HARVESTER INSERTED THE BTT INTO THE INCISION AND BLEW UP THE BALLOON WITH A AIR IN A SLIP TIP SYRINGE. BALLOON AND BTT FUNCTIONED AS EXPECTED DURING THE DISSECTION PORTION. BTT SEAL WAS EXCHANGED AND CANNULA WAS SET UP AND HARVESTER BEGAN TRANSECTION. TOWARDS THE CONCLUSION OF THE TRANSECTION PORTION THE BTT SLID OUT FROM INCISION. HARVESTER DEFLATED THE BALLOON, SLIDE THE BTT BACK INTO THE INCISION. HE FILLED THE 30 CC SLIP TIP SYRINGE WITH AIR AND INJECTED THE MAJORITY OF THIS AIR INTO THE BALLOON. HE CONTINUED WITH TRANSECTION. ABOUT 3 MINUTES AFTER INFLATION THE BALLOON POPPED, IDENTIFIED BY AN AUDIBLE SOUND. THE TUNNEL REMAINED INTACT, THE HARVESTER FINISHED THE CASE WITH THE BTT WITHIN THE INCISION. NO PARTICLES FROM THE BALLOON WERE IDENTIFIED WITHIN THE TUNNEL. THERE WAS NO PATIENT HARM. THERE WAS NO DELAY IN THE EVH PROCEDURE. EVH PROCEDURE CONCLUDED AS NORMAL.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365103 VASOVIEW HEMPRO 3 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VH-6000 3000487726 00607567701274

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male UNKNOWN.