BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTRING III PROXIMAL SEAL 4.3 MM

    MDR report key: 1935528 · Received November 10, 2010

    Report

    Report Number
    2242352-2010-03263
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 12, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: VISUAL INSPECTION REVEALED THAT THE DELIVERY TUBE WAS RETURNED SEPARATE FROM THE LOADING DEVICE. THE TENSION SPRING ASSEMBLY WAS INSIDE THE DEPLOYMENT TUBE AND THE SEAL WAS EXTENDING OUT OF THE TUBE. THE BLUE STRING HAD BEEN PULLED FROM THE CENTER OF THE SEAL. THE GREEN SLIDE LOCK AND THE WHITE PLUNGER WERE DEPRESSED ON THE DELIVERY DEVICE. THERE WAS NO EVIDENCE OF BLOOD ON THE DEVICE. BASED UPON THE RECEIVED CONDITION OF THE DEVICE, THE REPORTED COMPLAINT "SEAL COULD NOT BE REMOVED FROM THE DELIVERY DEVICE" COULD NOT BE CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. 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 PROXIMAL SEAL COULD NOT BE REMOVED FROM THE DELIVERY DEVICE. ANOTHER SEAL WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL REPORTED NO PATIENT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTRING III PROXIMAL SEAL 4.3 MM PROXIMAL SEAL DXC MAQUET CARDIOVASCULAR, LLC HSK-3043 25014079

    Patients

    Seq Age Sex Outcome Treatment
    1 NA