BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1092743 · Received July 25, 2008

    Report

    Report Number
    3004939290-2008-00056
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 25, 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. THERE IS NO EVIDENCE TO SUGGEST THAT THE MYNX DEVICE DID NOT MEET SPECIFICATION OR PERFORM AS INTENDED PER IFU. BASED ON THE INFO PROVIDED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE RETROPERITONEAL BLEED IS UNK, HOWEVER, THE POSTERIOR WALL PUNCTURE, HIGH STICK, AND/OR INR COULD HAVE BEEN CONTRIBUTING FACTORS. PER THE MYNX IFU, "DO NOT USE THE MYNX VASCULAR CLOSURE DEVICE IF THE PUNCTURE SITE IS LOCATED ABOVE THE MOST INFERIOR BORDER OF THE INFERIOR EPIGASTRIC ARTERY (IEA) AND/OR ABOVE THE INGUINAL LIGAMENT BASED UPON BONY LANDMARKS, SINCE SUCH A PUNCTURE SITE MAY RESULT IN A RETROPERITONEAL HEMATOMA/BLEED. PERFORM A FEMORAL ANGIOGRAM TO VERIFY THE LOCATION OF THE PUNCTURE SITE. DO NOT USE THE MYNX VASCULAR CLOSURE DEVICE IF THE PUNCTURE IS THROUGH THE POSTERIOR WALL OR IF THERE ARE MULTIPLE PUNCTURES, AS SUCH PUNCTURES MAY RESULT IN A RETROPERITONEAL HEMATOMA/BLEED." IN ADDITION, THE SAFETY AND EFFECTIVENESS OF THE MYNX DEVICE HAVE NOT BEEN ESTABLISHED IN PTS WITH DOCUMENTED INR >1.5. MYNX SHOULD ONLY BE USED BY A TRAINED LICENSED PHYSICIAN OR HEALTHCARE PROFESSIONAL.

    Description of Event or Problem · 1

    A FEMALE UNDERWENT A CORONARY INTERVENTION IN 2008. PRE-PROCEDURAL MEDICATIONS INCLUDED COUMADIN (INR OF 1.6). IT WAS REPORTED THAT CFA ACCESS WAS COMPLICATED BY A POSTERIOR WALL STICK ALONG WITH BEING ABOVE THE INFERIOR EPIGASTRIC ARTERY. THE PHYSICIAN, NOT YET FULLY TRAINED TO THE MYNX PROCEDURE, PROCEEDED TO USE THE MYNX DEVICE WITHOUT AN ACI REP PRESENT. AFTER THE PROCEDURE, THE PT HAD COMPLAINTS OF DISCOMFORT IN THE ABDOMEN, AND IT WAS NOTED THAT A HEMATOMA HAD DEVELOPED. A CT SCAN DOCUMENTED RETROPERITONEAL BLEED, AND THE PT WAS SENT FOR VASCULAR REPAIR ON THE NEXT DAY IN WHICH 4 UNITS OF BLOOD WERE TRANSFUSED. THE PT TOLERATED THE PROCEDURE WELL AND WAS SCHEDULED TO DISCHARGE WITH NO FURTHER INCIDENT REPORTED. IT WAS REPORTED THAT THE SURGEON WAS UNABLE TO DETERMINE THE SOURCE OF THE BLEED. THE LAB DIRECTOR REPORTEDLY ASSESSED THE RETROPERITONEAL BLEED AS NOT BEING CAUSED BY THE MYNX DEVICE.

    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 70 YR Hospitalization INR OF 1.6| PRE-PROCEDURAL MEDICATIONS INCLUDED COUMADIN