BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIFLO

    MDR report key: 3987635 · Received July 25, 2014

    Report

    Report Number
    9612515-2014-00011
    Event Type
    Injury
    Date Received
    July 25, 2014
    Date of Event
    May 16, 2014
    Report Date
    July 25, 2014
    Manufacturer
    VASCUTEK LTD.
    Product Code
    DSY
    PMA / PMN Number
    K992832
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS NOT CURRENTLY KNOWN IF THERE IS ANY DEVICE MALFUNCTION UNTIL THE ANALYSIS IS COMPLETE. METHOD CODE: ANALYSIS IS CURRENTLY ONGOING AND IS NOT COMPLETE. RESULTS: A REVIEW OF THE PROCESS AND AVAILABLE MANUFACTURING RECORDS CONFIRMED THAT TH DEVICE WAS MANUFACTURER TO ITS DESIGNED SPECIFICATIONS.

    Description of Event or Problem · 1

    VASCUTEK LTD WAS MADE AWARE OF AN EVENT ON (B)(6) 2014 THAT OCCURRED IN (B)(6) ON (B)(6) 2014, THAT INVOLVED A VASCUTEK LTD. MANUFACTURED MAXIFO. SYNTHETIC VASCULAR GRAFT. THE INCIDENT WAS DESCRIBED AS FOLLOWS: "HIGH POROSITY OF BOTH EXTREMITIES OF THE GRAFT WHERE THE SOLID REINFORCEMENT WAS RETRIEVED, A HIGH TRANSPARENCY APPEARANCE OF THE GRAFT WALL. THIS LEAD TO A PROTAMINE INJECTION, THE USE OF BIOGLUE AND MECHANICAL COMPRESSION AFTER THE PROCEDURE ON THE GRAFT EXTERNAL SURFACE. THE PROCEDURE WAS PROLONGED BY MORE THAN 30 MINUTES DUE TO CONTINUOUS BLEEDING",

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436983 MAXIFLO EPTFE MAXIFLO VASCULAR PROTHESIS DSY VASCUTEK LTD. MAXIFLO 13371212 6399

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention