BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL SYSTEM 3.8MM

    MDR report key: 2080200 · Received April 7, 2011

    Report

    Report Number
    2242352-2011-00244
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 9, 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
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT THE DELIVERY TUBE WAS RETURNED SEPARATE FROM THE LOADING DEVICE. THE TENSION SPRING ASSEMBLY WAS INSIDE THE DELIVERY TUBE AND THE SEAL WAS EXTENDED OUTSIDE THE TUBE. THE SEAL HAD BEEN COMPLETELY UNRAVELED. THE GREEN SLIDE LOCK AND THE WHITE PLUNGER WERE DEPRESSED ON THE DELIVERY DEVICE. THE DEVICE WAS VERY BLOODY. TO FURTHER INVESTIGATE, THE SEAL WAS PULLED OUT OF THE DELIVERY TUBE. NO ISSUES WERE OBSERVED DURING THIS FUNCTIONAL TEST. BASED UPON THE RECEIVED CONDITION OF THE DEVICE, THE REPORT COMPLAINT "SEAL DID NOT DEPLOY PROPERLY" COULD NOT BE CONFIRMED. 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 A CORONARY ARTERY BYPASS PROCEDURE, TWO HEARTSTRING III SEALS DID NOT DEPLOY PROPERLY. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL 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 25025181

    Patients

    Seq Age Sex Outcome Treatment
    1 NA