BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW 7 XB

    MDR report key: 4838030 · Received June 9, 2015

    Report

    Report Number
    2242352-2015-00474
    Event Type
    Malfunction
    Date Received
    June 9, 2015
    Date of Event
    May 14, 2015
    Report Date
    May 14, 2015
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVAL. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. INTERNAL COMPLAINT NO: (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. SIGNS OF CLINICAL USAGE AND EVIDENCE OF BLOOD WERE OBSERVED. A VISUAL INSPECTION DETERMINED THAT THE HEATER WIRE WAS FLEXED AWAY FROM THE HOT JAW AND WAS DETACHED AT THE TIP. THE WIRE REMAINED IN PLACE AT THE BASE OF THE JAWS. BASED ON THE RETURNED CONDITION OF THE DEVICE THE REPORTED COMPLAINT WAS CONFIRMED FOR "BENT/DETACHED HEATER WIRE". THE CONFIRMED FAILURE MODE HAS BEEN INVESTIGATED IN THE CAPA. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INITIAL 3500A FORM HAD MANUFACTURER REPORT NUMBER: 2242352-2015-00475 FOR (B)(4). THE CORRECT MANUFACTURER REPORT NUMBER IS 2242352-2015-00474. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE USING VASOVIEW 7 XB, THE BALLOON BURST ON THE BTT PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372843 VASOVIEW 7 XB ENDOSPCI VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC. C-VH-3200 25113704

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR