BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 2200863 · Received August 8, 2011

    Report

    Report Number
    2242352-2011-01076
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CAN NOT BE PERFORMED. WE WILL, HOWEVER, CONTINUE TO MONITOR AND TREND THIS TYPE OF EVENT TO ENSURE THAT THERE IS NO COMPROMISE TO QUALITY. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED LOT NUMBER. THERE WERE NO NON CONFORMANCE ISSUE(S) WITH THIS PRODUCTION LOT. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, WHILE THE SURGEON WAS TAKING DOWN THE INTERNAL MAMMARY, HE WAS INFORMED BY ANESTHESIA THAT THE PATIENT'S PRESSURE WAS DROPPING AND EVENTUALLY SHE WAS WITHOUT A PRESSURE. AT THE SAME TIME, THE HARVESTER WAS IN THE LOWER THIGH DOING EVH. THE SURGEON OPENED THE PERICARDIUM AND SAW THAT THE HEART WAS DISTENDED WITH AIR. HE BEGAN OPEN CHEST MASSAGE AND THE PATIENT WAS GIVEN EPINEPHRINE. TEE SHOWED MASSIVE AMOUNTS OF AIR AND NO EVIDENCE OF ATRIAL SEPTAL DEFECT. EVH WAS HALTED AND THE CO2 TURNED OFF, PATIENT PLACED IN TRENDELENBURG POSITION AND THE CABG WAS COMPLETED WITHOUT FURTHER INCIDENCE. THE SURGEON FEELS THE PATIENT SHOULD HAVE NO ADVERSE OUTCOME. THE HARVESTER FINISHED THE CASE BY OPENING SMALL ADDITIONAL INCISIONS. THE HOSPITAL DID NOT REPORT ANY FURTHER PATIENT EFFECTS. THE HOSPITAL INDICATED THAT THE PRODUCT PERFORMED FINE AND THERE WAS NO MALFUNCTION. THE PRODUCT IS NOT RETURNING. INSUFFLATOR WAS AT 10 MM/HG PRESSURE AND 5 1/M FLOW. PATIENT'S CONDITION IS STABLE BUT SLOW TO WAKE UP. THE HARVESTER IS VERY EXPERIENCED. THE LOT NUMBER IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASO VIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-3000 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention