BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEM FLOW COUPLER DEVICE AND SYSTEM

    MDR report key: 1833682 · Received September 10, 2010

    Report

    Report Number
    2183620-2010-00047
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 17, 2010
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    MVR
    PMA / PMN Number
    K093310
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FLOW COUPLER WAS IMPLANTED ON (B)(6)2010 AND THEN EXPLANTED ON (B)(6)2010. ACCORDING TO THE DEVICE HISTORY RECORD, THE DEVICES MET SPECIFICATION AT THE TIME OF MANUFACTURE. THEN 100% FUNCTIONAL ALIGNMENT TESTING WAS PERFORMED ON EACH DEVICE AND 100% VISUAL INSPECTION WAS PERFORMED ON EACH ASSEMBLY DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    ON (B)(6)2010, PHYSICIAN PERFORMED A TONGUE RECONSTRUCTION WITH A 2.0 MM FLOW COUPLER. PHYSICIAN NOTED THAT THE VEIN WAS THIN-WALLED AND UPON PLACING THE VEIN ON THE RING PINS, THE VESSEL WAS "BREAKING", REQUIRING THE ANASTOMOSIS TO BE REDONE. THERE WAS NO FLOW AUDIO FROM THE MONITOR, ONLY STATIC NOISE. AN EXTERNAL DOPPLER WAS USED WHICH NOTED GOOD SOUND AND THE FLAP SHOWED NO SIGNS OF ISCHEMIA. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS SENT TO RECOVERY. AT AN UNSPECIFIED TIME LATER, THE PATIENT WAS TAKEN BACK TO THE OR FOR UNSPECIFIED REASONS, AT WHICH TIME BLEEDING WAS NOTED AT THE ANASTOMOSIS. PHYSICIAN REMOVED THE FLOW COUPLER AND HAND-SEWED THE ANASTOMOSIS. PHYSICIAN THOUGHT THERE MAY HAVE BEEN "PRESSURE CAUSED BY KINKING" WHICH CONTRIBUTED TO THE BLEEDING VESSEL. ANOTHER PHYSICIAN (FELLOW) NOTED THAT "THERE WAS A CLOT THAT NEEDED TO BE REMOVED IN THE VESSEL WITH THE 2.0 MM FLOW COUPLER. THE VESSEL WAS TOO SMALL FOR THE 2.0 MM FLOW COUPLER." PATIENT IS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEM FLOW COUPLER DEVICE AND SYSTEM ANASTOMOTIC COUPLER AND BLOOD FLOWMETER MVR SYNOVIS SURGICAL INNOVATIONS GEM2752-FC 5763123-1301724

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention