BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW 7 XB EVH SYSTEM

    MDR report key: 1912352 · Received November 3, 2010

    Report

    Report Number
    2242352-2010-03243
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 6, 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
    NJ, 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 AT THE END OF AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE DISSECTION TIP OF THE VASOVIEW 7 XB "BROKE INTO MULTIPLE PIECES INSIDE THE PATIENT'S LEG. THE TUNNEL WAS INSPECTED, THEN IRRIGATED AND SUCTIONED. SEVERAL PIECES OF THE TIP WERE EVACUATED." THE PROCEDURE WAS COMPLETED USING THE REPORTED DEVICE. THERE WERE NO OTHER PATIENT EFFECTS REPORTED. THE CORRECT LOT NUMBER COULD NOT BE OBTAINED. ON OCTOBER 28, 2010, RECEIVED USER FACILITY MEDWATCH REPORT #: 3100120000-2010-8036 WITH LOT NUMBER 25012330. THE REPORTED LOT NUMBER COULD NOT BE VERIFIED FOR THE REPORTED PART NUMBER. THE PRODUCT WAS RETAINED BY THE HOSPITAL AND MAY BE AVAILABLE FOR EVALUATION AT A FUTURE DATE.

    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