BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTRING III PROXIMAL SEAL SYSTEM, 3.8 MM

    MDR report key: 1922573 · Received November 19, 2010

    Report

    Report Number
    2242352-2010-03375
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 21, 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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: VISUAL INSPECTION REVEALED THAT THE DELIVERY TUBE WAS RETURNED ALONE WITHOUT THE LOADING DEVICE. THE TENSION SPRING ASSEMBLY WAS INSIDE THE DEPLOYMENT TUBE AND THE SEAL WAS ROLLED HALFWAY INSIDE THE TUBE. THE SEAL WAS CRACKED AND HAD ALSO 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 THE RECEIVED CONDITION OF THE DEVICE, THE REPORTED COMPLAINT "SEAL LOADED CORRECTLY BUT IT WAS CRACKED" WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO 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 PREPARATION FOR A CORONARY ARTERY BYPASS PROCEDURE, THE HEARTSTRING III PROXIMAL SEAL LOADED CORRECTLY BUT IT WAS CRACKED. THE SURGEON DID NOT DEPLOY THE CRACKED SEAL INTO THE PT AND INSTEAD USED ANOTHER KIT 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 25012304

    Patients

    Seq Age Sex Outcome Treatment
    1 NA