BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1082269 · Received July 25, 2008

    Report

    Report Number
    3004939290-2008-00053
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    June 21, 2008
    Report Date
    July 24, 2008
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    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 LOCAL REACTION IS UNK. THERE IS NO EVIDENCE TO SUGGEST THAT THE MYNX DEVICE DID NOT MEET SPECIFICATION OR PERFORM AS INTENDED PER IFU.

    Description of Event or Problem · 1

    A MALE PT, UNDERWENT A CATHETERIZATION PROCEDURE IN 2008. NO INTRA-PROCEDURAL DETAILS ARE AVAILABLE FROM THE SITE. AT THE END OF THE CATHETERIZATION PROCEDURE, MYNX VASCULAR CLOSURE WAS USED TO ACHIEVE FEMORAL ARTERY HEMOSTASIS. ONE DAY POST PROCEDURE, THE PT REPORTEDLY DEVELOPED MODERATE PAIN AT THE ACCESS SITE AND WAS RE-ADMITTED TO THE HOSP IN THE NEXT DAY WITH A LOCALIZED AREA OF REDNESS AND TENDERNESS. THE PT'S WHITE BLOOD COUNT WAS NORMAL AND THE CULTURE OF THE ACCESS SITE WAS NEGATIVE INDICATING THE ABSENCE OF AN INFECTION. DESPITE THE NEGATIVE CULTURE, THE PT WAS GIVEN PROPHYLACTIC IV ANTIBIOTICS DURING HOSPITALIZATION. THE PT WAS DISCHARGED ABOUT 5 DAYS LATER WITH REPORTEDLY LESS PAIN AND A SMALL BUMP. NO FURTHER INFO IS AVAILABLE. THE PHYSICIAN WHO PERFORMED THE ORIGINAL CATHETERIZATION PROCEDURE IS TRAINED TO USE MYNX AND INDICATED THAT THE MYNX DEVICE WAS PREPPED AND USED PER THE INSTRUCTIONS FOR USE (IFU).

    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 Hospitalization