BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW 6 PRO

    MDR report key: 3101436 · Received May 3, 2013

    Report

    Report Number
    2242352-2013-00412
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K091733
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVAL IS COMPLETED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, PART OF THE C-RING ON THE VASOVIEW 6 PRO BROKE OFF AND FELL INTO THE PT. THE PIECE WAS RETRIEVED THROUGH THE ORIGINAL INCISION. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. THE SURGEON AND EVENT DATE WERE NOT PROVIDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195333 VASOVIEW 6 PRO ENDOSCOPIC VESSEL HARVESTING DXC MAQUET CARDIOVASCULAR, LLC VH-2400 25068852

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other