BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HS III PROXIMAL SYSTEM 4.3MM

    MDR report key: 2040841 · Received March 23, 2011

    Report

    Report Number
    2242352-2011-00179
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 BODY OF THE LOADING DEVICE. THE GREEN SLIDE LOCK AND THE WHITE PLUNGER WERE DEPRESSED ON THE DELIVERY DEVICE. THERE WAS EVIDENCE OF BLOOD ON THE DEVICE. BASED UPON THE REC'D CONDITION OF THE DEVICE, THE REPORTED COMPLAINT "SEAL WOULD NOT LOAD PROPERLY" WAS CONFIRMED. A LOT HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE PRODUCT LOT NUMBER IS UNK. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE HEARTSTRING III SEAL WOULD NOT LOAD PROPERLY. A SIDE BITER CLAMP WAS USED TO COMPLETE THE PROCEDURE BECAUSE, THERE WERE NO MORE SEALS AVAILABLE. 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 SYSTEM 4.3MM PROXIMAL SEAL DXC MAQUET CARDIOVASCULAR, LLC HSK-3043 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other