BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.3MM HEARTSTRING III PROXIMAL SEAL SYSTEM

    MDR report key: 1587542 · Received January 13, 2010

    Report

    Report Number
    2242352-2009-00056
    Event Type
    Malfunction
    Date Received
    January 13, 2010
    Date of Event
    December 16, 2009
    Report Date
    December 17, 2009
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: MAQUET CARDIOVASCULAR RECEIVED THE DEVICE ON 21 DEC 2009. A VISUAL INSPECTION SHOWED THAT THE DELIVERY DEVICE WAS RETURNED WITH THE SEAL AND THE TENSION SPRING ASSEMBLY, OUTSIDE OF THE TUBE. THE SEAL WAS INTACT. THE GREEN SLIDE LOCK AND THE WHITE PLUNGER WERE ACTIVATED (DEPLOYED POSITION) ON THE DELIVERY DEVICE. THERE WAS ALSO EVIDENCE OF BLOOD ON THE DEVICE. BASED UPON THE RECEIVED CONDITION OF THE DEVICE, THE SEAL WAS DEPLOYED FROM THE DELIVERY DEVICE. THE REPORTED FAILURE "THE SEAL DID NOT DEPLOY OUT OF THE DELIVERY TUBE" CAN NOT BE CONFIRMED. A LOT HISTORY RECORD REVIEW WAS NOT CONDUCTED AS THE LOT NUMBER WAS UNK. INVESTIGATION HAS BEEN COMPLETED, AND BASED ON OUR INVESTIGATION, THE EXACT ROOT CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED. (B) (4)

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT, DURING A CORONARY ARTERY BYPASS PROCEDURE, THE SEAL ON THE HEARTSTRING III PROXIMAL SEAL SYSTEM DID NOT DEPLOY OUT OF THE DELIVERY DEVICE. PROCEDURE WAS COMPLETED WITH ANOTHER SEAL WITH SAME DEVICE. THE HOSPITAL REPORTED NO PT EFFECTS. REPLACEMENT WAS REQUESTED. IT WAS INITIALLY REPORTED THAT THE PRODUCT HAD BEEN DISCARDED, HOWEVER, PRODUCT WAS RETURNED TO MAQUET CARDIOVASCULAR, LLC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.3MM HEARTSTRING III PROXIMAL SEAL SYSTEM HEARTSTRING SEAL DXC MAQUET CARDIOVASCULAR, LLC HS-3045 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA