BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL

    MDR report key: 3915827 · Received June 12, 2014

    Report

    Report Number
    2242352-2014-00663
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    April 25, 2014
    Report Date
    May 16, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVAL. IT SHOWED NO SIGNS OF CLINICAL USAGE AND SLIGHT EVIDENCE OF BLOOD. THE DELIVERY DEVICE WAS RETURNED INSIDE THE LOADING DEVICE. THE SEAL, TENSION SPRING ASSEMBLY AND THE ANCHOR TAB WERE INSIDE THE LOADING DEVICE. THE SEAL WAS FOLDED IN THE DELIVERY TUBE AND A PORTION OF THE LOCK BUTTON WERE BLUE, NOT GREEN AS STATED IN THE EVENT DESCRIPTION. THE BLUE SLIDE LOCK WAS NOT ACTIVATED AND THE WHITE PLUNGER WAS NOT DEPRESSED ON THE DELIVERY DEVICE. BASED UPON THE RECEIVED CONDITION OF THE DEVICE THE REPORTED COMPLAINT WAS CONFIRMED FOR FAILURE TO LOAD. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT #. THERE WAS NO NON CONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING PREP FOR A CORONARY ARTERY BYPASS PROCEDURE, THE HEARTSTRING III FAILED TO LOAD PROPERLY. THE GREEN BUTTONS WERE HELD ON THE HEARTSTRING III HOWEVER THE SEAL WAS NO SET PROPERLY AND IT BECAME DEFORMED AND CRACKED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346810 HS III PROXIMAL SEAL ENDOSCOPIC VESSEL HARVESTING DXC MAQUET CARDIOVASCULAR, LLC HS-3045 25093255

    Patients

    Seq Age Sex Outcome Treatment
    1