BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1880174 · Received October 22, 2010

    Report

    Report Number
    3004939290-2010-00116
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    September 18, 2010
    Report Date
    October 4, 2010
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 PATIENT AND PROCEDURAL INFORMATION PROVIDED, THE CAUSE OF THE REPORTED RETROPERITONEAL HEMATOMA IS INCONCLUSIVE. THERE WAS NO INFORMATION PROVIDED REGARDING THE PRE-PROCEDURAL FEMORAL ANGIOGRAM TO ASSESS SUITABILITY OF CLOSURE. IN ADDITION, NO INFORMATION WAS PROVIDED REGARDING THE DEPLOYMENT OF THE MYNX AND ITS USE PER THE INSTRUCTIONS FOR USE. THE REVIEW OF THE LHR (LOT # F1016508) INDICATED THAT THE MYNX DEVICE MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE ACI SALES PROFESSIONAL ON (B)(4) 2010 THAT A (B)(6) FEMALE PATIENT WITH A HISTORY OF HYPERTENSION AND HIGH CHOLESTEROL PRESENTED TO THE EMERGENCY ROOM WITH ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI) AND UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE ON (B)(6) 2010. HEPARIN WAS ADMINISTERED PERI-PROCEDURE. THERE WAS NO INFORMATION PROVIDED REGARDING THE FEMORAL ANGIOGRAM PRIOR TO MYNX TO ASSESS SUITABILITY OF CLOSURE. MYNX WAS USED FOR FEMORAL ARTERY CLOSURE FOLLOWING THE PROCEDURE. NO INFORMATION WAS PROVIDED REGARDING THE DEPLOYMENT OF THE MYNX AND ITS USE PER THE INSTRUCTIONS FOR USE, ALTHOUGH THE DEPLOYER OF THE DEVICE IS A TRAINED USER. POST DEPLOYMENT, IT WAS REPORTED THAT THERE WAS PERSISTENT OOZING AND MANUAL COMPRESSION WAS HELD FOR 20 MINUTES. HEMOSTASIS WAS ACHIEVED. THE PATIENT WAS TRANSFERRED TO THE FLOOR WITHOUT INCIDENT. IT WAS REPORTED THAT 30 MINUTES LATER, THE PATIENT DEVELOPED A HEMATOMA. A CT SCAN REVEALED A MILD-TO-MODERATE RETROPERITONEAL HEMATOMA ON THE RIGHT SIDE WHICH EXTENDED SLIGHTLY TO THE LEFT SIDE. A SMALL HEMATOMA WAS NOTED IN THE RIGHT GROIN WITH NO ORGANIZED FLUID COLLECTION IN THE GROIN. THIS WAS ASSESSED BY THE PHYSICIAN TO BE MYNX RELATED. THE PATIENT WAS TRANSFUSED AN UNKNOWN AMOUNT OF BLOOD AND ADMITTED TO THE INTENSIVE CARE UNIT AS STANDARD PROTOCOL FOR STEMI. AT THE TIME OF REPORT, THE PATIENT REMAINS IN THE HOSPITAL WITH CLOSTRIDIUM DIFFICILE (C-DIFF) AND ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) WHICH ARE UNRELATED TO MYNX. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX VASCULAR CLOSURE DEVICE MGB MGB ACCESSCLOSURE, INC. MX6700 F1016508

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention HEPARIN