BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMASHIELD GOLD WOVEN D.V. AORTIC ARCH VASC.

    MDR report key: 3000006 · Received March 8, 2013

    Report

    Report Number
    2242352-2013-00213
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 13, 2013
    Manufacturer
    MAQUET CADIOVASCULAR, LLC
    Product Code
    DSY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. IT WAS RECEIVED IN ITS ORIGINAL CARTON AND SEALED BLISTER PACKAGING. A VISUAL INSPECTION DETERMINED THAT THERE WERE AREAS WHERE THE COLLAGEN COATING APPEARED DARKER IN SOME AREAS OF THE GRAFT. THIS DISCOLORATION IS CONSISTENT WITH THAT OF THE AGING OF THE GRAFT AFTER STERILIZATION, AND IS CONSIDERED COSMETIC IN NATURE. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE IS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION, THE COLLAGEN COATING OF HEMASHILED GOLD WOVEN D.V. AORTIC ARCH VASCULAR GRAFT APPEARED TO BE DISCOLORED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98767 HEMASHIELD GOLD WOVEN D.V. AORTIC ARCH VASC. VASCULAR GRAFT DSY MAQUET CADIOVASCULAR, LLC VS02175920P0 12106191

    Patients

    Seq Age Sex Outcome Treatment
    1 NA