BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HS III PROXIMAL SEAL SYSTEM 3.8MM

    MDR report key: 4924215 · Received July 16, 2015

    Report

    Report Number
    2242352-2015-00570
    Event Type
    Injury
    Date Received
    July 16, 2015
    Date of Event
    June 17, 2015
    Report Date
    June 18, 2015
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS NOT RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION; THEREFORE IT COULD NOT BE EVALUATED. IT WAS STATED THAT THE DEVICE USED WAS DISCARDED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS NOT RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION; THEREFORE IT COULD NOT BE EVALUATED. THE REP STATED THAT THE CUTTER USED WAS DISCARDED. THE CUTTER AND HEARTSTRING RETURNED WERE NOT COMPLAINT RELATED. A REVIEW OF THE CERTIFICATE OF CONFORMITY (C OF C) FOR THE REPORTED DEVICE WAS CONDUCTED. THE VENDOR CERTIFIES THAT THE PRODUCT HAS BEEN MANUFACTURED IN ACCORDANCE WITH APPLICABLE CUSTOMER SPECIFICATIONS AND DRAWINGS. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, HS III PROXIMAL SEAL SYSTEM 3.8MM AORTA CUTTER MALFUNCTIONED AND CAUSED PATIENT 400 ML BLOOD LOSS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, HS III PROXIMAL SEAL SYSTEM 4.3MM AORTA CUTTER MALFUNCTIONED AND CAUSED PATIENT 400 ML BLOOD LOSS. DEVICE IS NOT RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463545 HS III PROXIMAL SEAL SYSTEM 3.8MM PROXIMAL SEAL SYSTEM DXC MAQUET CARDIOVASCULAR LLC C-HSK-3043 25103338

    Patients

    Seq Age Sex Outcome Treatment
    1 Other