BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTRING III PROXIMAL SEAL SYSTEM, 3.8 MM

    MDR report key: 2012213 · Received February 1, 2011

    Report

    Report Number
    2242352-2011-00006
    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
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: VISUAL INSPECTION REVEALED NO NON CONFORMITIES WITH THE CUTTER. THE BUTTON AND SAFETY LOCK WERE DEPRESSED. THE CUTTER HAD BEEN ACTUATED AND THE CUTTER AND NEEDLE WERE EXTENDED. THE DEVICE WAS BLOODY. THE DISTANCE BETWEEN THE AORTIC STOP TO THE EDGE OF THE CUTTING TUBE WAS MEASURED AND WAS FOUND TO BE WITHIN SPECIFICATIONS. BASED UPON THESE FINDINGS, THE REPORTED FAILURE "TIP OF THE AORTIC CUTTER WENT OUT TOO FAR AND THE SPRING MISFIRED" COULD NOT BE CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE TIP OF THE AORTIC CUTTER WENT OUT TOO FAR AND THE SPRING MISFIRED. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PT EFFECTS. THE PRODUCT WAS RETURNED.

    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 25022681

    Patients

    Seq Age Sex Outcome Treatment
    1 NA