BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 2132809 · Received June 17, 2011

    Report

    Report Number
    3004939290-2011-00129
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED BALLOON LOSS OF PRESSURE WAS CAUSED BY A LONGITUDINAL TEAR THAT UPON VISUAL INSPECTION AT HIGH MAGNIFICATION WAS CONFIRMED AS THE SOURCE OF THE LEAK. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION PERFORMED, THE PROBABLE CAUSE OF THE TEAR COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (LOT F1102004) INDICATED THAT THE MYNX DEVICE MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI SALES PROFESSIONAL THAT A MALE PATIENT UNDERWENT AN INTERVENTIONAL CORONARY PROCEDURE ON (B)(6) 2011. ACCESS INTO THE COMMON FEMORAL ARTERY (CFA) WAS OBTAINED VIA A 6F PROCEDURAL SHEATH. A PRE-PROCEDURAL FEMORAL ANGIOGRAM WAS TAKEN AND SHOWED A NORMAL ARTERY WITH NO SIGN OF CALCIUM. POST PROCEDURE, THE PHYSICIAN WHO IS A TRAINED USER OF THE MYNX, CHOSE THE DEVICE FOR FEMORAL ARTERIAL CLOSURE. IT WAS REPORTED THAT WHEN THE PHYSICIAN RETRACTED THE DEVICE BACK AGAINST THE ARTERIOTOMY, A BALLOON RUPTURE OCCURRED. THE PHYSICIAN REMOVED THE DEVICE AS A WHOLE UNIT. SINCE ACCESS WAS NOT LOST, THE PHYSICIAN PREPPED AND DEPLOYED A SECOND MYNX DEVICE. IT WAS REPORTED THAT UPON DEVICE PULLBACK TO ABUT AGAINST THE ARTERIOTOMY, AGAIN, A BALLOON RUPTURE OCCURRED. THE PHYSICIAN CONVERTED THE PATIENT TO MANUAL COMPRESSION WHERE SUCCESSFUL HEMOSTASIS WAS ACHIEVED. THE PATIENT WAS AMBULATED AND DISCHARGED WITH NO REPORT OF PATIENT CLINICAL SEQUELA. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX VASCULAR CLOSURE DEVICE MGB MGB ACCESSCLOSURE, INC. MX6700 F1102004

    Patients

    Seq Age Sex Outcome Treatment
    1