BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMA 4 BRANCH 24MM PLATINUM GRAFT

    MDR report key: 3941720 · Received March 5, 2014

    Report

    Report Number
    2242352-2014-00208
    Event Type
    Malfunction
    Date Received
    March 5, 2014
    Date of Event
    February 5, 2014
    Report Date
    February 7, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    MAL
    PMA / PMN Number
    K021213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. THE DEVICE WAS RETURNED IN ITS ORIGINAL CARTON, ALONG WITH THE GRAFT SIZERS, PATIENT LABELS, AND INSTRUCTIONS FOR USE. BOTH THE INNER AND OUTER BLISTERS REMAINED SEALED. VISUAL INSPECTION DETERMINED THAT THERE WERE SOME AREAS ON THE DEVICE THAT WERE DARKER IN COLOR THAN OTHER AREAS. THIS TYPE OF DISCOLORATION IS CONSISTENT WITH COLLAGEN COATED GRAFTS AFTER STERILIZATION. THE DISCOLORATION IS COSMETIC IN NATURE. BASED UPON THE RECEIVED CONDITION OF THE DEVICE, THE REPORTED COMPLAINT WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THER WAS NO NON-CONFORMANCE RECORDED IN THE LOT HISTORY. INTERNAL COMPLAINT NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN AORTIC DISSECTION, THE COLLAGEN COATING ON THE HEMASHIELD PLAT WDV GRAFT WAS MELTED (DISCOLORED). A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131648 HEMA 4 BRANCH 24MM PLATINUM GRAFT VASCULAR GRAFT MAL MAQUET CARDIOVASCULAR, LLC M00202175924P0 12443833

    Patients

    Seq Age Sex Outcome Treatment
    1 NI