BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 2132813 · Received June 17, 2011

    Report

    Report Number
    3004939290-2011-00131
    Event Type
    Injury
    Date Received
    June 17, 2011
    Report Date
    May 20, 2011
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED AND THE CONDITION OF THE RETURNED DEVICE, THE REPORTED FAILURE TO DEFLATE COULD NOT BE CONFIRMED. THE RETURNED DEVICE WAS VISUALLY INSPECTED AND BASED ON THE INVESTIGATION PERFORMED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (LOT F1031601) 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 A PATIENT UNDERWENT A DIAGNOSTIC CORONARY CATHETERIZATION PROCEDURE (EXACT DATE UNKNOWN). ACCESS WAS OBTAINED AT THE COMMON FEMORAL ARTERY. A PRE-PROCEDURAL FEMORAL ANGIOGRAM SHOWED NO PRESENCE OF CALCIFICATION. POST PROCEDURE, THE PHYSICIAN WHO IS A TRAINED USER OF THE MYNX, CHOSE THE DEVICE FOR FEMORAL ARTERIAL CLOSURE. IT WAS REPORTED THAT WHEN THE PHYSICIAN ATTEMPTED TO DEFLATE THE BALLOON IN ORDER TO REMOVE IT, THE BALLOON WOULD NOT DEFLATE. A VASCULAR SURGEON WAS CALLED IN AND USED AN ACCESS NEEDLE TO DEFLATE THE BALLOON. THE PATIENT WAS CONVERTED TO MANUAL COMPRESSION WHERE SUCCESSFUL HEMOSTASIS WAS ACHIEVED. THE PATIENT WAS AMBULATED AND DISCHARGED WITH NO REPORTED CLINICAL SEQUELA. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX VASCULAR CLOSURE DEVICE MGB MGB ACCESSCLOSURE, INC. MX6700 F1031601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention