BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8 MM 60CM HEMASHIELD MDV

    MDR report key: 4296651 · Received November 24, 2014

    Report

    Report Number
    2242352-2014-01311
    Event Type
    Injury
    Date Received
    November 24, 2014
    Date of Event
    November 17, 2014
    Report Date
    November 18, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    MAL
    PMA / PMN Number
    K954848
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. 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 A THORATIC ENDOVASCULAR AORTIC REPAIR FOR A PATIENT WITH A THORACIC AORTIC ANEURYSM A 8MM 60CM HEMASHIELD MDV GRAFT WAS USED A BLOOD TRANSMISSION. THE LOCATION WAS LEFT SUBCLAVIAN. DURING THE PROCEDURE, A BLOOD LEAK WAS NOTED FROM WHOLE SURFACE OF ABOUT 20-30 PROXIMAL PART OF THE GRAFT. THE SURGEON USED GAUZE TO STOP THE BLEEDING. THE GRAFT WAS SUTURED TO THE RIGHT VESSEL TO COMPLETE THE PROCEDURE. THE TOTAL AMOUNT OF BLOOD LEAKAGE WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762149 8 MM 60CM HEMASHIELD MDV VASCULAR GRAFT MAL MAQUET CARDIOVASCULAR, LLC M002020952080 25094517

    Patients

    Seq Age Sex Outcome Treatment
    1 Other