BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1140972 · Received August 27, 2008

    Report

    Report Number
    3004939290-2008-00069
    Event Type
    Injury
    Date Received
    August 27, 2008
    Report Date
    August 27, 2008
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL AND THE DEVICE'S LOT NUMBER WAS NOT PROVIDED TO PERFORM LOT HISTORY REVIEW. BASED ON THE INFO PROVIDED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE REPORTED INCIDENT IS UNK. THERE IS NO EVIDENCE TO SUGGEST THAT THE MYNX DEVICE DID NOT MEET SPEC OR PERFORM AS INTENDED PER IFU.

    Description of Event or Problem · 1

    IN 2008, A FEMALE PT UNDERWENT A DIAGNOSTIC CARDIAC CATHETERIZATION PROCEDURE PERFORMED THROUGH A 6 FR PROCEDURAL SHEATH PLACED IN THE COMMON FEMORAL ARTERY. AT THE END OF THE PROCEDURE, THE PHYSICIAN, A TRAINED MYNX OPERATOR, DEPLOYED A MYNX VASCULAR CLOSURE DEVICE TO ACHIEVE ACCESS SITE HEMOSTASIS. THE MYNX DEVICE WAS REPORTEDLY DEPLOYED WITHOUT INCIDENT FOLLOWING PROCEDURE STEPS DESCRIBED IN THE INSTRUCTIONS FOR USE. AN ADDITIONAL 10 MINUTES OF ADJUNCTIVE COMPRESSION WAS APPLIED FOLLOWING DELIVERY OF THE MYNX DEVICE, WHICH IS ROUTINE PRACTICE FOR THIS OPERATOR. THE PT WAS DISCHARGED PER HOSP PROTOCOL AND WITHOUT INCIDENT. OF NOTE, THE PT HAS HAD 12 PRIOR CATHETERIZATION PROCEDURES IN THE IPSILATERAL SIDE WITH PERMANENT CLOSURE DEVICE COMPONENTS LEFT BEHIND. THE FOLLOWING WEEK, THE PT RETURNED TO THE HOSPITAL WITH SYMPTOMS OF ACCESS SITE PAIN AND LOCAL SWELLING. DOPPLER ULTRASOUND CONFIRMED THE PRESENCE OF A PSEUDOANEURYSM. THE SIZE WAS NOT REPORTED AND THEREFORE REMAINS UNK. THE PT WAS ADMITTED TO THE HOSPITAL FOR VASCULAR REPAIR OF THE PSEUDOANEURYSM AND WAS REPORTEDLY DOING WELL FOLLOWING SURGERY WITH NO LASTING OR ADDITIONAL CLINICAL SEQUELAE. NO OTHER INFO CONCERNING THIS EVENT IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R