BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE

    MDR report key: 3942521 · Received July 17, 2014

    Report

    Report Number
    3004939290-2014-00087
    Event Type
    Injury
    Date Received
    July 17, 2014
    Report Date
    June 12, 2014
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED WITH THE SHUTTLE CARTRIDGE ENGAGED TO THE HANDLE. THE SEALANT AND SEALANT SLEEVE REMAINED IN THEIR MANUFACTURED POSITION. VISUAL INSPECTION OF THE DEVICE SHOWED THAT THERE WAS NO SALINE SOLUTION IN THE BALLOON AND IN THE INFLATION TUBE. FAILURE TO PURGE THE DEVICE OF AIR DURING THE PREP PHASE CAN CAUSE THE BALLOON TO PARTIALLY COLLAPSE AS THE AIR IN THE SYSTEM IS COMPRESSED, RESULTING IN THE BALLOON PULLING THROUGH THE ARTERIOTOMY. THE BALLOON WAS INFLATED WITH FLUID AND VERIFIED IN A GO/NO GO GAUGE TO BE WITHIN SPECIFICATION. THE REVIEW OF THE LHR (LOT F1408507) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT. BASED ON THE PROVIDED INFORMATION AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE BALLOON PULL THROUGH COULD HAVE BEEN DUE TO THE INSTRUCTION FOR USE (IFU) NOT BEING FOLLOWED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE USER FACILITY REPORTED TO THE ACI SALES REPRESENTATIVE THAT THEY HAD A "FAILED DEVICE" NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME. ON (B)(6) 2014, IT WAS REPORTED TO THE ACI SALE REPRESENTATIVE THAT A PATIENT UNDERWENT A PERIPHERAL INTERVENTIONAL PROCEDURE ON AN UNKNOWN DATE. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS A TRAINED USER, SELECTED A MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE BALLOON LOST PRESSURE AND CAME OUT OF THE PATIENT ALONG WITH THE 7F SHEATH. A FEMOSTOP WAS USED TO OBTAIN HEMOSTASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418280 MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE MGB MGB ACCESSCLOSURE, INC. MX6721 F1408507

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention