BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 2071916 · Received April 28, 2011

    Report

    Report Number
    3004939290-2011-00103
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED AND THE CONDITION OF THE RETURNED DEVICE, THE REPORTED DEVICE RETRACTION JAM COULD NOT BE CONFIRMED AND THE CAUSE COULD NOT BE DETERMINED. BASED ON THE PROVIDED INFORMATION AND THE INVESTIGATION PERFORMED, THE PROBABLE CAUSE OF THE NOTED BALLOON PROXIMAL BOND DETACHMENT COULD NOT BE CONCLUSIVELY DETERMINED. THE BALLOON PROXIMAL BOND WAS DETACHED AND BUNCHED AT THE DISTAL TIP OF THE ADVANCER TUBE. VISUAL INSPECTION REVEALED THAT THE DISTAL BALLOON SHAFT WAS INVERTED WITH THE CORE WIRE EXPOSED. DAMAGE WAS NOTED TO THE DISTAL TIP OF THE ADVANCER TUBE. THE REVIEW OF THE LHR (LOT F1101104) 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 FEMALE PATIENT UNDERWENT AN INTERVENTIONAL CORONARY CATHETERIZATION PROCEDURE ON (B)(6) 2011. ACCESS WAS OBTAINED AT THE RIGHT COMMON FEMORAL ARTERY (CFA) VIA A 6F PROCEDURAL SHEATH. A PRE-PROCEDURAL FEMORAL ANGIOGRAM SHOWED THE VESSEL TO BE CLEAN. FOLLOWING THE PROCEDURE, THE PHYSICIAN TRAINED TO THE MYNX PROCEDURE, CHOSE THE DEVICE TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE DEVICE WAS PREPPED AND USED PER THE INSTRUCTION FOR USE (IFU). REPORTEDLY, AFTER THE SEALANT WAS DEPLOYED, THE PHYSICIAN ENCOUNTERED A LOT OF RESISTANCE REMOVING THE DEVICE FROM THE ADVANCER TUBE. THE PHYSICIAN REMOVED THE DEVICE AS A WHOLE AND IT WAS REPORTED THAT HEMOSTASIS WAS ACHIEVED WITH THE MYNX. THE PATIENT WAS AMBULATED AND DISCHARGED TO HOME WITHOUT REPORT OF PATIENT CLINICAL SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX VASCULAR CLOSURE DEVICE MGB MGB ACCESSCLOSURE, INC. MX6701 F1101104

    Patients

    Seq Age Sex Outcome Treatment
    1