BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL

    MDR report key: 3901737 · Received May 5, 2014

    Report

    Report Number
    2242352-2014-00505
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 8, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. IT SHOWED NO SIGNS OF CLINICAL USAGE OR EVIDENCE OF BLOOD. THE LOADING DEVICE WAS NOT RETURNED. THE TENSION SPRING ASSEMBLY AND ANCHOR TAB WERE INSIDE THE TUBE OF THE DELIVERY DEVICE. THE SEAL WAS EXTENDED OUTSIDE OF THE DELIVERY TUBE; IT REMAINED ANCHORED ON THE TENSION SPRING ASSEMBLY. THE GREEN SLIDE LOCK WAS LOCKED AND WHITE PLUNGER WAS NOT DEPRESSED ON THE DELIVERY DEVICE. BASED UPON THE EVALUATION RESULTS, THE REPORTED COMPLAINT WAS CONFIRMED FOR FAILURE TO LOAD. ADDITIONAL EVALUATION REQUIRED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED. A LOT HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE PRODUCT LOT NUMBER IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS PROCEDURE, WHILE LOADING THE HEARTSTRING III THE SCRUB TECH OBSERVED A "CRIMP" IN THE PROXIMAL SEAL WHERE THE OUTER RING WAS UNRAVELING. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268115 HS III PROXIMAL SEAL ENDOSCOPIC VESSEL HARVESTING DXC MAQUET CARDIOVASCULAR, LLC HS-3045

    Patients

    Seq Age Sex Outcome Treatment
    1