BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1933516 · Received December 20, 2010

    Report

    Report Number
    3004939290-2010-00139
    Event Type
    Injury
    Date Received
    December 20, 2010
    Report Date
    November 24, 2010
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED UPON THE INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE WAS NO INFORMATION PROVIDED REGARDING THE DEPLOYMENT OF THE MYNX. IT WAS REPORTED THAT THE PHYSICIAN PERFORMED A FEMORAL ANGIOGRAM WHICH REVEALED AN OCCLUSION IN THE CFA. THE PATIENT WAS ADMINISTERED HEPARIN (NUMBER OF UNITS UNKNOWN) WHICH REPORTEDLY CLEARED THE OCCLUSION. HOWEVER WITHOUT THE MATERIAL TO PERFORM CHEMICAL ANALYSIS, THE COMPOSITION OF THE MATERIAL COULD NOT BE CONCLUSIVELY 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 BY THE ACI SALES PROFESSIONAL THAT A PATIENT UNDERWENT A DIAGNOSTIC CORONARY HEART CATHETERIZATION PROCEDURE (EXACT DATE UNKNOWN). ACCESS WAS OBTAINED VIA A 6F PROCEDURAL SHEATH AT THE COMMON FEMORAL ARTERY. A PRE-PROCEDURAL FEMORAL ANGIOGRAM DID NOT SHOW ANY PRESENCE OF CALCIUM. FOLLOWING THE PROCEDURE, THE PHYSICIAN TRAINED TO THE USE OF THE MYNX, CHOSE THE DEVICE FOR FEMORAL ARTERIAL CLOSURE. THERE WAS NO INFORMATION PROVIDED REGARDING THE STEPS PERFORMED IN THE DEPLOYMENT OF THE MYNX. THERE WAS NO REPORT OF COMPLICATION DURING THE PROCEDURE OR CLOSURE. REPORTEDLY, WHILE THE PATIENT WAS IN THE HOLDING AREA POST PROCEDURE, THE PATIENT COMPLAINED OF LEG PAIN. IT WAS ASSESSED THAT THERE WERE NO DISTAL PULSES. THE PATIENT WAS SENT BACK TO THE CATH LAB WHERE ANOTHER PHYSICIAN PERFORMED A FEMORAL ANGIOGRAM WHICH REVEALED AN OCCLUSION IN THE CFA. THE PATIENT WAS ADMINISTERED HEPARIN (NUMBER OF UNITS UNKNOWN) WHICH REPORTEDLY CLEARED THE OCCLUSION. THE PATIENT WAS KEPT OVERNIGHT FOR OBSERVATION AND WAS DISCHARGED THE FOLLOWING DAY WITHOUT FURTHER CLINICAL SEQUELA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HEPARIN