BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW 7 XB EVH SYSTEM

    MDR report key: 1893090 · Received October 29, 2010

    Report

    Report Number
    2242352-2010-03199
    Event Type
    Injury
    Date Received
    October 29, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 30, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE IS RECEIVED AND THE INVESTIGATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE CONICAL TIP OF THE VASOVIEW 7 XB BROKE OFF IN THE PT'S LEG. THE SURGEON HAD TO OPEN THE PT'S LEG TO RETRIEVE THE PIECE WITH NO OTHER PT EFFECTS REPORTED. THE LOT NUMBER IS UNK. THE PRODUCT WAS RETAINED BY THE HOSPITAL, BUT MAY BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW 7 XB EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC. VH-3200 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention