BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTRING III PROXIMAL SEAL SYSTEM, 3.8 MM

    MDR report key: 2012210 · Received February 1, 2011

    Report

    Report Number
    2242352-2011-00013
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    December 29, 2010
    Report Date
    January 3, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: VISUAL INSPECTION REVEALED THAT THE DELIVERY TUBE WAS RETURNED SEPARATE FROM THE LOADING DEVICE. THE SEAL AND THE TENSION SPRING ASSEMBLY WERE INSIDE THE DELIVERY TUBE. THE SEAL WAS ROLLED BUT EXTENDED MORE THAN HALFWAY OUTSIDE THE TUBE. THE END STRAND OF THE SEAL HAD STARTED TO UNRAVEL. THE GREEN SLIDE LOCK AND THE WHITE PLUNGER WERE NOT DEPRESSED ON THE DELIVERY DEVICE. THERE WAS NO EVIDENCE OF BLOOD ON THE DEVICE. BASED UPON THESE FINDINGS, THE REPORTED FAILURE WAS CONFIRMED AS "SEAL DID NOT LOAD PROPERLY". A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. 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, "WHEN THE CONE WAS PUSHED INTO AORTA COULD NOT PUSH INTO THE TUBE." THIS IS INTERPRETED AS THE SEAL WOULD NOT DEPLOY. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PT EFFECTS. UPON RECEIPT OF THE PRODUCT, IT APPEARED THAT THE SEAL FAILED TO LOAD PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTRING III PROXIMAL SEAL SYSTEM, 3.8 MM PROXIMAL SEAL DXC MAQUET CARDIOVASCULAR, LLC HSK-3038 25025181

    Patients

    Seq Age Sex Outcome Treatment
    1 NA