BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASIVIEW HEMOPRO 2

    MDR report key: 3893751 · Received June 10, 2014

    Report

    Report Number
    2242352-2014-00673
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 14, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVAL CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR LOTS 25095629, 25095131, AND 25094443, THE LAST 3 LOTS SHIPPED TO THE ACCOUNT PRIOR TO THE AWARE DATE. (THE EVENT DATE IS NOT AVAILABLE.) THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. INTERNAL COMPLAINT # - (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE C-RING BROKE ON THE VASOVIEW HEMOPRO 2 AND FELL INTO THE PT'S LEG. THE DEVICE WAS USED TO RETRIEVE THE PIECE FROM THE PT. THE DISSECTION TIP WAS USED TO CREATE THE TUNNEL AND PROXIMAL INSUFFLATION WAS BEING USED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341274 VASIVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR VH-4000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other