BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL SYSTEM 3.8MM

    MDR report key: 2182495 · Received July 11, 2011

    Report

    Report Number
    2242352-2011-00901
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 16, 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
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT THE DELIVERY TUBE WAS RETURNED INSIDE THE LOADING DEVICE. THE SEAL AND THE TENSION SPRING ASSEMBLY WERE INSIDE THE LOADING DEVICE, UNDER THE WINDOW. THE SEAL HAD CRACKED ALONG THE SECOND RING FROM THE EDGE. THE DELIVERY TUBE HAD BEEN PUSHED AGAINST THE SEAL, CAUSING IT TO FOLD UPWARDS. THE GREEN SLIDE LOCK AND THE WHITE PLUNGER WERE NOT DEPRESSED ON THE DELIVERY DEVICE. THERE WAS SLIGHT EVIDENCE OF BLOOD ON THE DEVICE. BASED UPON THE RECEIVED CONDITION OF THE DEVICE, THE REPORTED COMPLAINT "SEAL WAS "CRUMPLED"" WAS CONFIRMED, HOWEVER, IT COULD NOT BE CONFIRMED THAT IT WAS "CRUMPLED" OUT OF PACKAGE. 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 HOSP REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS PROCEDURE, THE HEARTSTRING III SEAL WAS "CRUMPLED" OUT OF PACKAGE AND WAS NOT ABLE TO ROLL PROPERLY. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HS III PROXIMAL SEAL SYSTEM 3.8MM PROXIMAL SEAL DXC MAQUET CARDIOVASCULAR, LLC. HSK-3038 25033585

    Patients

    Seq Age Sex Outcome Treatment
    1 NA