BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 2170714 · Received July 21, 2011

    Report

    Report Number
    3004939290-2011-00160
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 21, 2011
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE AND THE PROCEDURAL SHEATH WERE NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INFORMATION PROVIDED AND NO RETURNED DEVICE FOR PHYSICAL INVESTIGATION, THE REPORTED EVENT COULD NOT BE CONFIRMED AND THE ROOT CAUSE 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 BY THE ACI SALES PROFESSIONAL THAT A PATIENT UNDERWENT A DIAGNOSTIC PERIPHERAL PROCEDURE ON (B)(6) 2011. ACCESS WAS OBTAINED AT THE COMMON FEMORAL ARTERY (CFA) VIA A 6F PROCEDURAL SHEATH. A PRE-PROCEDURAL FEMORAL ANGIOGRAM REVEALED PRESENCE OF CALCIUM AT THE VICINITY OF THE ARTERIOTOMY. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS A TRAINED USER OF THE MYNX CHOSE THE DEVICE FOR FEMORAL ARTERY CLOSURE. IT WAS REPORTED THAT UPON BALLOON RETRACTION TO ABUT AGAINST THE ARTERIOTOMY, A BALLOON RUPTURE OCCURRED. THE PHYSICIAN REMOVED THE DEVICE AND CONVERTED THE PATIENT TO MANUAL COMPRESSION. SUCCESSFUL HEMOSTASIS WAS ACHIEVED. THE PATIENT WAS AMBULATED AND DISCHARGED TO HOME WITHOUT PATIENT CLINICAL SEQUELA REPORTED. 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. MX6701 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1