BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL SYSTEM 3.8MM

    MDR report key: 2093126 · Received April 15, 2011

    Report

    Report Number
    2242352-2011-00280
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT THE CUTTER CASING HAD SPLIT APART FROM ONE END. THE BUTTON AND SAFETY LOCK WERE DEPRESSED. THE CUTTER HAD BEEN ACTUATED AND THE CUTTER AND NEEDLE WERE EXTENDED. THERE WAS SLIGHT EVIDENCE OF BLOOD ON THE DEVICE. BASED UPON THE RECEIVED CONDITION OF THE DEVICE, THE REPORTED COMPLAINT "AORTIC CUTTER CASING SPLIT APART" 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. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE HEARTSTRING III AORTIC CUTTER CASING SPLIT APART. THIS OCCURRED TWICE. WHEN THE SURGEON ACTUATED THE CUTTER, THE CASING SPLIT APART AND THE NEEDLE CAME OUT AT A STRANGE ANGLE. HE STATED THAT THE CUTTER FELT FRAGILE. HE WAS ABLE TO COMPLETE ONE AORTOTOMY WITH THE FIRST CUTTER, AND MAY HAVE NEEDED TO OPEN ANOTHER UNIT FOR THE SECOND AORTOTOMY. THE HOSPITAL STAFF DOES NOT KNOW IF A NEW KIT WAS NEEDED OR NOT. THEREFORE, EITHER THE SAME OR A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY 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 25025181

    Patients

    Seq Age Sex Outcome Treatment
    1 NA