BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL SYTEM 3.8MM

    MDR report key: 3770396 · Received February 18, 2014

    Report

    Report Number
    2242352-2014-00119
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Report Date
    January 22, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVAL. IT SHOWED SIGNS OF CLINICAL USAGE. THERE WAS A SIGNIFICANT AMOUNT OF BLOOD ON THE DELIVERY DEVICE, INSIDE THE DELIVERY TUBE AND ON THE SEAL. THE LOADING DEVICE WAS NOT RETURNED. THE SEAL WAS EXTENDED OUTSIDE OF THE DELIVERY TUBE; IT REMAINED ANCHORED TO THE TENSION SPRING ASSEMBLY. THE SPRING ASSEMBLY WAS ADVANCED ABOUT A THIRD OF IT WAS OUTSIDE OF THE DELIVERY TUBE. THE GREEN SLIDE LOCK WAS UNLOCKED AND WHITE PLUNGER WAS DEPRESSED ON THE DELIVERY DEVICE. ADDITIONAL EVAL IS REQUIRED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVAL IS COMPLETED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NON-CONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE HEARTSTRING III SEAL DID NOT COMPLETELY OPEN WHEN DEPLOYED WITHIN THE AORTA. A SECOND HEARTSTRING III WAS USED AND THE SEAL DID NOT DEPLOY COMPLETELY FROM THE DELIVERY DEVICE WHEN THE PLUNGER WAS PUSHED. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103158 HS III PROXIMAL SEAL SYTEM 3.8MM ENDOSCOPIC VESSEL HARVESTING DXC MAQUET CARDIOVASCULAR, LLC HSK-3038 25085064

    Patients

    Seq Age Sex Outcome Treatment
    1 NI