BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1894511 · Received November 9, 2010

    Report

    Report Number
    3004939290-2010-00119
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 13, 2010
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION PERFORMED, THE CAUSE OF THE REPORTED DIFFICULT TO DEFLATE BALLOON COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, IT WAS REPORTED THAT THE USER CUT THE SHUTTLE AND WIRE IN TWO IN AN ATTEMPT TO DEFLATE THE BALLOON. ALTHOUGH IT IS UNKNOWN IF AN ATTEMPT WAS MADE TO REMOVE THE DEVICE AS A WHOLE, IT SHOULD BE NOTED THAT THE IFU DEVICE REMOVAL STEP INCLUDES THE FOLLOWING STATEMENT: NOTE: IF UNUSUAL RESISTANCE IS FELT DURING CATHETER WITHDRAWAL, PULL THE ADVANCER TUBE AND BALLOON CATHETER TOGETHER THROUGH THE TISSUE TRACT. THE DEVICE WAS DISSECTED IN AN ATTEMPT TO REMOVE THE BALLOON DURING THE CLOSURE PROCEDURE. THE CONDITION OF THE RETURNED DEVICE AS RECEIVED EXHIBITED A CATHETER LUMEN THAT WAS CUT FROM THE CATHETER HANDLE. THE DISTAL SEGMENT OF THE SHAFT WAS NOT RETURNED. VISUAL INSPECTION REVEALED THAT THE BALLOON WAS DETACHED AND THE BALLOON DISTAL TIP WAS INVERTED AND BUNCHED UP. A LONGITUDINAL-TEAR WAS OBSERVED ON THE BALLOON, AND THE PROXIMAL BALLOON BOND WAS ALSO DAMAGED. THE CORE WIRE WAS CUT DISTAL TO THE BALLOON WITH A BEND IN THE DISTAL END. THE ADVANCER TUBE WAS CUT AT THE PROXIMAL END AND THE DISTAL TIP WAS FREE OF DAMAGE. DUE TO THE DISSECTED AND SEPARATE DEVICE COMPONENTS, AND ONE OF THE COMPONENTS NOT BEING RETURNED FOR INVESTIGATION, THE CAUSE OF FAILURE COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (LOT F1023201) INDICATED THAT THE MYNX DEVICE MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI SALES PROFESSIONAL THAT FOLLOWING A CATHETERIZATION PROCEDURE (NO DETAILS PROVIDED), MYNX WAS USED FOR FEMORAL ARTERY CLOSURE. DURING THE PROCEDURE, THE USER EXPERIENCED DIFFICULTY DEFLATING THE BALLOON. AFTER SEVERAL ATTEMPTS TO DEFLATE THE BALLOON, THE USER CUT THE SHUTTLE AND WIRE IN TWO. A SMALL NEEDLE WAS THEN PASSED OVER THE WIRE IN AN ATTEMPT TO POP THE BALLOON AND IN DOING SO, THE BALLOON AND WIRE WERE SHEARED OFF. THE DEVICE WAS THEN REPORTEDLY CUT IN TWO ABOVE THE BALLOON. IT WAS REPORTED THAT THE BALLOON WIRE ASSEMBLY SUBSEQUENTLY WENT DOWN THE COMMON FEMORAL ARTERY. THEY RE-ACCESSED (IPSILATERAL) WITH AN ANTEGRADE APPROACH AND WERE ABLE TO SNARE THE MATERIAL. ON 10/26/10, ACI RECEIVED A COPY OF A MEDWATCH FROM THE USER FACILITY WHICH ALSO REPORTED THAT PHYSICIAN WAS ABLE TO SNARE THE TIP, AND THE BALLOON AND REMOVE THEM SUCCESSFULLY. THE PATIENT IS REPORTED TO BE DOING FINE WITH NO FURTHER CLINICAL SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX VASCULAR CLOSURE DEVICE MGB MGB ACCESSCLOSURE, INC. MX6700 F1023201

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention