BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWCOUPLER, 3.0 MM

    MDR report key: 5200544 · Received October 27, 2015

    Report

    Report Number
    5200544
    Event Type
    Malfunction
    Date Received
    October 27, 2015
    Date of Event
    September 2, 2015
    Report Date
    September 2, 2015
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    MVR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    1

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 3.0 MM GEM MICROVASCULAR ANASTOMOTIC FLOW-COUPLER WAS IMPLANTED DURING A FREE ALT FLAP FROM THIGH TO NECK (PHARYNX) PROCEDURE. THE FLOW-COUPLER WAS PLACED ON THE FLAP VEIN (DESCENDING LATERAL FEMORAL CIRCUMFLEX VEIN) TO BRANCH OF INTERNAL JUGULAR VEIN IN THE LEFT NECK. THE PT WAS TAKEN TO THE ICU AND THE PHYSICIAN CONFIRMED GOOD VENOUS FLOW VIA FLOW-COUPLER DOPPLER SIGNAL. TWO DAYS POST-OP THE PHYSICIAN NOTED A LOSS OF FLOW-COUPLER DOPPLER SIGNAL. THE PT WAS TAKEN BACK TO SURGERY. THE SURGEON REMOVED THE FLOW-COUPLER DOPPLER PROBE FROM THE PT AND IMPLANTED A COOK BRAND DOPPLER CUFF TO MONITOR THE BURIED PHARYNGEAL FLAP. THE COUPLED VENOUS ANASTOMOSIS WAS LEFT INTACT. THE FLOW-COUPLER RINGS REMAIN IMPLANTED. PT OUTCOME IS GOOD. MFR #2032282-2015-00019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711296 FLOWCOUPLER, 3.0 MM ANASTOMOTIC COUPLER AND FLOW METER/MVR MVR SYNOVIS SURGICAL INNOVATIONS GEM2754-FC SPSGT14-12L0008

    Patients

    Seq Age Sex Outcome Treatment
    1 NI