BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUS CORONARY SHUNT 1.75 MM

    MDR report key: 2191034 · Received July 19, 2011

    Report

    Report Number
    2242352-2011-00969
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    May 25, 2011
    Report Date
    June 24, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT THE COIL END SHUNT TIP HAD BEEN BROKEN OFF IN HALF BY THE LUMEN. THE NON-COIL END SHUNT TIP WAS RECEIVED ATTACHED TO THE THREAD AND TAB. THERE WAS NO EVIDENCE OF BLOOD ON THE DEVICE. BASED UPON THE RECEIVED CONDITION OF THE DEVICE, THE REPORTED COMPLAINT 'SHUNT WAS FOUND BROKEN AT THE TIME OF REMOVAL" WAS 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 HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE SHUNT WAS FOUND BROKEN AT THE TIME OF REMOVAL. THE COMPLAINT REPORT STATED "WHEN THE USER FINISHED THE SUTURE PROCEDURE, HE WANTED TO TAKE IT OUT BUT HE FOUND OF-1750 HAD ALREADY BROKEN". A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIUS CORONARY SHUNT 1.75 MM CLAMPLESS BEATING HEART DXC MAQUET CARDIOVASCULAR, LLC OF-1750 25008603

    Patients

    Seq Age Sex Outcome Treatment
    1 NA