BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW HEMOPRO 2 EVH SYSTEM

    MDR report key: 2140923 · Received June 21, 2011

    Report

    Report Number
    2242352-2011-00674
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 27, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE HAS NOT BEEN RETURNED TO MAQUET CARDIOVASCULAR FOR INVESTIGATION. WE WILL CONTINUE PURSUING THE DEVICE BEING RETURNED BY THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND THE INVESTIGATION IS COMPLETED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO 2 HEATER WIRE LIFTED UP FROM THE JAW. THIS WAS NOTICED WHEN THE HARVESTER TOOK OUT THE DEVICE FROM THE LEG DURING HARVESTING BECAUSE SHE THOUGHT THE JAWS WERE NOT ALIGNED PROPERLY. THERE WAS EXCESSIVE BLEEDING IN THE LEG BECAUSE OF THE DEVICE'S INABILITY TO CAUTERIZE. A BRIDGING TECHNIQUE WAS USED IN THE LOWER LEG TO CAUTERIZE THE REST OF THE BRANCHES AND STOP THE BLEEDING (USING CAUTERY). A REPLACEMENT UNIT WAS USED TO COMPLETE HARVESTING THE UPPER LEG. THE HOSPITAL DID NOT REPORT ANY FURTHER PATIENT EFFECTS. THE PRODUCT IS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO 2 EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-4000 25032728

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other