BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HS III PROXIMAL SEAL SYSTEM 3.8MM

    MDR report key: 2023316 · Received February 15, 2011

    Report

    Report Number
    2242352-2011-00141
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 2011
    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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED NO NON CONFORMITIES WITH THE CUTTER. THE BUTTON AND SAFETY LOCK WERE DEPRESSED. THE CUTTER HAD BEEN ACTUATED AND THE CUTTER AND NEEDLE WERE EXTENDED. THE AORTIC PLUG WAS PRESENT, BUT ONLY ABOUT HALF OF IT. THE DEVICE WAS BLOODY. BASED UPON THE REC'D CONDITION OF THE DEVICE, THE REPORTED COMPLAINT "AORTIC CUTTER DID NOT COMPLETELY PENETRATE THROUGH THE INTIMA LAYER OF THE AORTA" WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, 3.8MM HEARTSTRING CUTTER WAS USED TO CREATE AN ARTERIOTOMY FOLLOWED BY THE DEPLOYMENT OF A HEARTSTRING SEAL. THE SEAL WAS DEPLOYED, BUT DID NOT ADEQUATELY SEAL THE ARTERIOTOMY AND BLOOD WAS STILL EXCESSIVELY COMING OUT AROUND THE SEAL. THIS SEAL WAS REMOVED AND A SECOND SEAL OPENED AND DEPLOYED. WHEN THE SECOND SEAL WAS DEPLOYED, THE SAME LACK OF TEMPORARY HEMOSTASIS OCCURRED. THIS SEAL WAS SUBSEQUENTLY REMOVED AND A SIDE BITER CLAMP APPLIED. UPON REVIEW OF THE ARTERIOTOMY IT WAS DISCOVERED THAT THE HS AORTIC CUTTER DID NOT COMPLETELY PENETRATE THROUGH THE INTIMA LAYER OF THE AORTA AND THE HS SEAL WAS NOT ABLE TO PROPERLY BE INSERTED. THE ARTERIOTOMY WAS REPAIRED AND ANOTHER SITE WAS SELECTED FOR THE GRAFT ANASTOMOSIS. ANOTHER HS WAS USED WITHOUT ISSUE. THE HOSPITAL DID NOT REPORT ANY FURTHER PT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HS III PROXIMAL SEAL SYSTEM 3.8MM AORTIC CUTTER DXC MAQUET CARDIOVASCULAR, LLC HSK-3038 25025809

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other