BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 2242009 · Received September 9, 2011

    Report

    Report Number
    3004939290-2011-00197
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    July 29, 2011
    Report Date
    August 12, 2011
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 INFORMATION PROVIDED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. A REVIEW OF THE LHR WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT PROVIDED. HOWEVER, PRODUCT RELEASE AT ACI IS CONTINGENT UPON THE SUCCESSFUL COMPLETION OF LOT RELEASE TESTING AND A DOCUMENTATION REVIEW BY THE QUALITY DEPARTMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE ACI SALES PROFESSIONAL ON (B)(4) 2011 THAT A (B)(6) FEMALE PATIENT WITH A HISTORY OF STENT IMPLANTATION UNDERWENT AN INTERVENTIONAL CATHETERIZATION PROCEDURE ON (B)(6) 2011. IT WAS REPORTED THAT THE STICK WAS LOW AT THE RIGHT GROIN AND PERI-PROCEDURE MEDICATIONS GIVEN TO THE PATIENT INCLUDED 8000 UNITS OF HEPARIN AND INTEGRILIN VIA AN IV DRIP. PLAVIX WAS GIVEN POST PROCEDURE. THERE WAS NO REPORTED COMPLICATION DURING THE PROCEDURE. NO INFORMATION WAS GIVEN REGARDING THE DEPLOYMENT STEPS TAKEN WHEN USING THE MYNX. POST CATHETERIZATION, WHILE STILL ON THE CATH LAB TABLE, A REGISTERED NURSE (RN) NOTICED A HEMATOMA AT THE ACCESS SITE WHICH WAS STILL PRESENT WHEN THE PATIENT WAS IN RECOVERY. IT WAS UNKNOWN WHETHER TREATMENT WAS GIVEN FOR THE HEMATOMA. AT 1.5 HOURS POST PROCEDURE, THE PATIENT'S BLOOD PRESSURE DROPPED AND THE PATIENT REPORTEDLY CODED. A VASCULAR SURGEON (VS) WAS CONTACTED AND THE PATIENT WAS BROUGHT IMMEDIATELY TO THE OPERATING ROOM (OR) WHERE THE VS REPAIRED THE PATIENT'S ARTERY AND TREATED A LARGE HEMATOMA THAT HAD MIGRATED DOWN THE PATIENT'S LEG. SIMULTANEOUS TO THE SURGERY, THE PATIENT WAS TRANSFUSED AN UNKNOWN NUMBER OF UNITS OF BLOOD. THE TRANSFUSION CAUSED THE STENTS TO THROMBOSE AND THEREFORE THE PATIENT UNDERWENT ANOTHER CATHETERIZATION PROCEDURE ON (B)(6) 2011 TO OPEN UP THE ARTERIES. IT WAS REPORTED THAT IN THE EARLY MORNING HOURS OF (B)(6) 2011, THE PATIENT BEGAN HAVING ANTERIOR WALL ISCHEMIA AS SHOWN ON AN EKG. THE PATIENT CODED AND HOSPITAL STAFF PERFORMED CARDIO PULMONARY RESUSCITATION (CPR), HOWEVER THE PATIENT EXPIRED. THE POST MORTEM SHOWED PERICARDIAL PERFUSION CAUSED BY A RUPTURED LEFT VENTRICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX VASCULAR CLOSURE DEVICE MGB MGB ACCESSCLOSURE, INC. MX6701 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death INTEGRILIN (INTRAVENOUS DRIP)| HEPARIN (8000 UNITS)