BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 870923 · Received June 25, 2007

    Report

    Report Number
    3004939290-2007-00001
    Event Type
    Injury
    Date Received
    June 25, 2007
    Date of Event
    June 6, 2007
    Report Date
    June 25, 2007
    Manufacturer
    ACCESS CLOSURE, 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 REVIEW OF THE LOT HISTORY RECORD DID NOT EXHIBIT ANY ISSUES THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. THE DEVICE WAS NOT RETURNED FOR EVAL AND NO OTHER INFO, INDICATING THAT THE DEVICE DID NOT PERFORM AS INTENDED, WAS PROVIDED AT THIS TIME. THERE IS NO EVIDENCE THAT SUGGESTS THE DEVICE DID NOT MEET SPECIFICATIONS.

    Description of Event or Problem · 1

    AN FEMALE PT, DIAGNOSED WITH PAD, UNDERWENT A PERIPHERAL INTERVENTION PROCEDURE, IN WHICH 3 SHEATH EXCHANGES WERE PERFORMED. NO PROCEDURAL COMPLICATIONS WERE REPORTED. INFO WAS REQUESTED, BUT NOT PROVIDED ON PREVIOUS CATH EXPERIENCE, RISK FACTORS FOR CLOSURE DEVICE COMPLICATIONS, OR HISTORY OF HYPERTENSION. THE MYNX PROCEDURE WAS REPORTED TO BE PERFORMED PER IFU WITHOUT COMPLICATIONS DURING THE PROCEDURE. IMMEDIATELY AFTER THE PROCEDURE, THE PT DEVELOPED A "GRAPE-FRUIT SIZED" HEMATOMA, IN WHICH ADD'L MANUAL COMPRESSION WAS APPLIED. SUBSEQUENTLY, A 3-4 G/DL DROP IN HEMOGLOBIN WAS NOTED, AND SHE WAS TRANSFUSED TWO UNITS OF BLOOD. ADD'L INFO WAS REQUESTED AND IS STILL PENDING, INCLUDING POST PROCEDURE ACT, EVIDENCE OF OTHER TYPES OF BLEEDING, PRE-CATH AND PROCEDURAL HEMOGLOBIN. PT REMAINED IN THE HOSPITAL ONE ADD'L DAY BEFORE DISCHARGE WITHOUT FURTHER INCIDENT. THE PHYSICIAN ASSESSED THE COMPLICATION AS RELATED OR POSSIBLY RELATED TO THE MYNX DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX VASCULAR CLOSURE DEVICE MYNX VASCULAR CLOSURE DEVICE MGB ACCESS CLOSURE, INC. MX6700 10000470

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R PERI-PROCEDURAL ANGIOMAX AND PROTAMINE| PROCEDURE.| PRE-PROCEDURE MEDICATIONS INCLUDE ASA| ADMINISTERED.| COUMADIN THERAPY WAS STOPPED 4 DAYS PRIOR TO