BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW 6 EVH SYSTEM

    MDR report key: 1934192 · Received December 8, 2010

    Report

    Report Number
    2242352-2010-03561
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 9, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: VISUAL INSPECTION REVEALED THAT THE DELIVERY TUBE WAS RETURNED SEPARATE FROM THE LOADING DEVICE. THE SEAL AND THE TENSION SPRING ASSEMBLY WERE INSIDE THE BODY OF THE LOADING DEVICE. THE GREEN SLIDE LOCK AND THE WHITE PLUNGER WERE DEPRESSED ON THE DELIVERY DEVICE. THERE WAS SLIGHT EVIDENCE OF BLOOD ON THE DEVICE. BASED UPON THE RECEIVED CONDITION OF THE DEVICE, THE REPORTED COMPLAINT "SEAL WOULD NOT LOAD" WAS CONFIRMED. 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 A CORONARY ARTERY BYPASS PROCEDURE, THE HEARTSTRING III PROXIMAL SEAL WOULD NOT LOAD. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW 6 EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-2000 25010836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA