BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTEGRAFT AG640

    MDR report key: 3123828 · Received May 15, 2013

    Report

    Report Number
    2247686-2013-00001
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 17, 2013
    Report Date
    May 15, 2013
    Manufacturer
    ARTEGRAFT, INC.
    Product Code
    LXA
    PMA / PMN Number
    N16837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ARTEGRAFT AG640, CONTROL #(B)(4), WAS DISCARDED AT THE HOSPITAL AFTER THE ATTEMPTED USE. EVALUATION OF THE ACTUAL MEDICAL DEVICE CANNOT BE COMPLETED. NO OTHER COMPLAINTS RECEIVED RELATED TO BATCH #(B)(4). (B)(4), HEALTH HAZARD ANALYSIS, AND FURTHER INVESTIGATION DOCUMENTATION HAVE BEEN INITIATED. RESULTS AND CONCLUSIONS WILL BE MAINTAINED WITHIN THE ARTEGRAFT COMPLAINT FILE #(B)(4).

    Description of Event or Problem · 1

    AN ARTEGRAFT DISTRIBUTOR WAS CONTACTED BY AN END-USER HOSPITAL REQUESTING CREDIT FOR AN ARTEGRAFT AG640, CONTROL #(B)(4). THE FIRST REPORT RECEIVED BY ARTEGRAFT, INC. INVOLVING ARTEGRAFT AG640, CONTROL #(B)(4) IS THAT THE DOCTOR DECIDED TO DISCARD THE IDENTIFIED GRAFT AFTER HE FOUND A HOLE IN THE GRAFT, AND HE FELT THE GRAFT LOOKED OF POOR QUALITY. THIS ORIGINAL HOLE WAS NOTICED DURING THE NORMAL SALINE IRRIGATION PROCESS PRIOR TO SURGERY. INFORMATION PROVIDED TO ARTEGRAFT, INC. AT A LATER TIME INDICATED THAT THE DOCTOR HAD REPAIRED THE ORIGINAL HOLE AND CONTINUED TO USE THE REPAIRED GRAFT FOR THE SURGERY. UPON ANASTOMOSIS, THE DOCTOR NOTICED A COUPLE MORE HOLES IN THE GRAFT THAT WERE NOT VISIBLE DURING THE PRE-SURGICAL FLUSHING PROCESS. AN ALTERNATE GRAFT WAS USED TO COMPLETE THE SURGERY. THE IDENTIFIED GRAFT WAS DISPOSED OF AT THE HOSPITAL AFTER THE SURGERY; THEREFORE, IT COULD NOT BE RETURNED TO ARTEGRAFT, INC. FOR FURTHER EVALUATION. NO ADDITIONAL COMPLAINTS HAVE BEEN RECEIVED RELATED TO BATCH #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214870 ARTEGRAFT AG640 VASCULAR GRAFT LXA ARTEGRAFT, INC. AG640 13B036

    Patients

    Seq Age Sex Outcome Treatment
    1