BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIUS CORONARY SHUNT 1.5 MM

    MDR report key: 2496411 · Received March 15, 2012

    Report

    Report Number
    2242352-2012-00305
    Event Type
    Injury
    Date Received
    March 15, 2012
    Date of Event
    March 10, 2012
    Report Date
    March 12, 2012
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K010117
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. WE WILL CONTINUE PURSUING THE DEVICE BEING RETURNED BY THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE AXIUS CORONARY SHUNT WAS ATTEMPTED TO BE PLACED INTO THE ARTERY AND THE CONICAL TIP FRACTURED OFF OF THE SPRING (COIL END OF THE LUMEN). BOTH PIECES WERE EXTRACTED THROUGH THE ORIGINAL ARTERIOTOMY. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT EFFECTS. THE HOSP INTENDS TO RETURN THE PRODUCT IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIUS CORONARY SHUNT 1.5 MM CLAMPLESS BEATING HEART DXC MAQUET CARDIOVASCULAR, LLC OF-1500 25033235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other