BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1981859 · Received February 8, 2011

    Report

    Report Number
    3004939290-2011-00008
    Event Type
    Injury
    Date Received
    February 8, 2011
    Report Date
    January 12, 2011
    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

    BASED ON THE INFORMATION PROVIDED AND THE CONDITION OF THE DEVICE, THE CAUSE OF THE FAILURE COULD NOT BE CONCLUSIVELY DETERMINED. VISUAL INSPECTION AND THE CONDITION OF THE DEVICE INVESTIGATED SUGGESTS OVER-SHUTTLING DURING DEVICE DEPLOYMENT. 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

    THE ACI SALES PROFESSIONAL REPORTED THAT ON (B)(6) 2011, HE WAS MADE AWARE OF AN EVENT WHERE A PATIENT UNDERWENT A DIAGNOSTIC CORONARY CATHETERIZATION PROCEDURE (EXACT TIMEFRAME, THE TYPE OF PROCEDURE AND PATIENT DETAILS NOT PROVIDED). ACCESS WAS OBTAINED VIA A 6F PROCEDURAL SHEATH AT THE COMMON FEMORAL ARTERY. THERE WAS NO REPORT OF PRE-PROCEDURAL ANGIOGRAM TO ASSESS THE SUITABILITY OF CLOSURE. THERE WAS NO INFORMATION PROVIDED REGARDING THE STEPS PERFORMED IN THE DEPLOYMENT OF THE MYNX. FOLLOWING THE PROCEDURE, THE PHYSICIAN, A TRAINED USER OF THE MYNX DEVICE AND PROCEDURE, CHOSE THE DEVICE TO CLOSE THE FEMORAL ACCESS SITE. IT WAS REPORTED THAT UPON BALLOON DEFLATION, THE BALLOON FAILED TO DEFLATE. A BIGGER SYRINGE WAS UTILIZED IN AN ATTEMPT TO DEFLATE THE BALLOON BUT WAS NOT SUCCESSFUL. THE PHYSICIAN USED "EXTREME FORCE" AND WAS ABLE TO PULL THE DEVICE OUT OF THE ARTERIOTOMY SUCCESSFULLY. HOWEVER, IT WAS OBSERVED THAT THE BALLOON HAD POTENTIALLY BROKEN OFF FROM THE DEVICE. IT WAS REPORTED THAT THE BALLOON HAD TRAVELLED MID WAY DOWN TO THE PATIENT'S THIGH. THE PATIENT WAS TAKEN TO SURGERY WHERE A CUT DOWN WAS PERFORMED AND THE BALLOON WAS REMOVED FROM THE PATIENT'S LEG. IT WAS REPORTED THAT THE PATIENT WAS DISCHARGED HOME (EXACT DATE NOT PROVIDED).

    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