BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1792277 · Received August 10, 2010

    Report

    Report Number
    3004939290-2010-00088
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 13, 2010
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE LIMITED INFORMATION PROVIDED AND NO RETURNED DEVICE FOR PHYSICAL INVESTIGATION, THE CAUSE OF THE REPORTED RETROPERITONEAL BLEED COULD NOT BE DETERMINED. HOWEVER, IT WAS REPORTED THAT PERI-PROCEDURE THE PATIENT WAS PLACED ON AN INTEGRILIN DRIP, A GLYCOPROTEIN IIB/IIIA (GPIIB/IIIA) INHIBITOR. IN ADDITION, IT WAS REPORTED THAT THE STICK WAS BORDERLINE HIGH, NEAR THE INFERIOR EPIGASTRIC ARTERY. PER THE MYNX INSTRUCTIONS FOR USE (IFU) THE SAFETY AND EFFECTIVENESS OF THE MYNX HAVE NOT BEEN ESTABLISHED IN PATIENTS WHO ARE CURRENTLY RECEIVING GLYCOPROTEIN IIB/IIIA PLATELET INHIBITORS. ADDITIONALLY, THE MYNX IFU STATES: 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. HEMOSTASIS WAS ACHIEVED WITH THE MYNX. THERE IS NO EVIDENCE TO SUGGEST THE DEVICE DID NOT MEET SPECIFICATION OR PERFORM AS INTENDED. THE REVIEW OF THE LHR (LOT F1005702) INDICATED THAT THE MYNX DEVICE MET ALL PERFORMANCE SPECIFICATIONS UPON SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE ACI SALES PROFESSIONAL ON (B)(4) 2010 THAT A (B)(6) MALE PATIENT UNDERWENT A CORONARY INTERVENTION ON (B)(6) 2010. THE STICK LOCATION WAS REPORTED TO BE BORDERLINE HIGH, NEAR THE INFERIOR EPIGASTRIC ARTERY BUT STILL AT THE FEMORAL HEAD. THE PATIENT WAS ADMINISTERED ANGIOMAX PERI-PROCEDURE ALONG WITH AN INTEGRILIN DRIP. THE PATIENT'S BLOOD PRESSURE (BP) DURING THE PROCEDURE WAS 120/80. FOLLOWING THE PROCEDURE, THE PHYSICIAN, A TRAINED USER OF THE MYNX, USED THE DEVICE FOR FEMORAL ARTERIAL CLOSURE. THERE WERE NO REPORTED COMPLICATIONS DURING PROCEDURE. HEMOSTASIS WAS ACHIEVED AFTER HOLDING 10 MINUTES OF PRESSURE. THE PATIENT WAS MOVED TO RECOVERY WHERE HE COMPLAINED OF GROIN PAIN. ECCHYMOSIS ON THE ABDOMEN WAS PRESENT. THE PATIENT'S BP DROPPED AND HE WAS IMMEDIATELY TAKEN FOR A CT SCAN WHERE A RETROPERITONEAL BLEED WAS CONFIRMED. THE PATIENT WAS TREATED WITH COMPRESSION AND BLOOD TRANSFUSION (NUMBER OF UNITS UNKNOWN) AND DISCHARGED THE FOLLOWING DAY ON (B)(6) 2010 WITH NO FURTHER CLINICAL SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX VASCULAR CLOSURE DEVICE MGB MGB ACCESSCLOSURE, INC. MX6700 F1005702

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention INTEGRILIN DRIP| ANGIOMAX, PERI-PROCEDURE