BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HS III PROXIMAL SEAL SYSTEM 3.8MM

    MDR report key: 3250027 · Received July 24, 2013

    Report

    Report Number
    2242352-2013-00700
    Event Type
    Injury
    Date Received
    July 24, 2013
    Date of Event
    June 27, 2013
    Report Date
    July 2, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    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 OR ADD'L INFO BECOMES AVAILABLE. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE USING THE HEARTSTRING III, THE AORTA WAS PUNCTURED ABNORMALLY WHICH CREATED AN OVAL SHAPED AORTOTOMY; THE SEAL DID NOT CREATE HEMOSTASIS UPON DEPLOYMENT. A REPLACEMENT DEVICE WAS USED AS THE SURGEON ATTRIBUTED THE PROBLEM TO THE SEAL. THE SEAL DID NOT CREATE HEMOSTASIS AND A CLAMP WAS USED TO COMPLETE THE PROCEDURE. IT WAS OBSERVED AFTER THE PROCEDURE THAT THE NEEDLE ON THE AORTIC CUTTER WAS BENT. WE ARE FOLLOWING UP WITH THE HOSPITAL TO OBTAIN THE PT'S CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346359 HS III PROXIMAL SEAL SYSTEM 3.8MM CLAMPLESS BEATING HEART DXC MAQUET CARDIOVASCULAR, LLC HSK-3038 25071704

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention