BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 1993697 · Received January 6, 2011

    Report

    Report Number
    2242352-2010-03910
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 9, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, IT WAS VERY DIFFICULT TO INSERT THE HEMOPRO INTO THE CANNULA. THE SILICON PART (BOOT) OF THE JAW APPEARED DAMAGED. NO PIECES FELL OFF INSIDE THE PT'S LEG. THERE WERE NO PT EFFECTS. THE PRODUCT IS RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25023416

    Patients

    Seq Age Sex Outcome Treatment
    1 NA