BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX CADENCE VASCULAR CLOSURE DEVICE 5F

    MDR report key: 3191913 · Received June 27, 2013

    Report

    Report Number
    3004939290-2013-00155
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    April 9, 2013
    Report Date
    May 29, 2013
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS 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. THE REVIEW OF THE LHR (LOT F1233802) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, ACI RECEIVED A COPY OF A MEDWATCH REPORT (B)(4), WHICH WAS SUBMITTED TO THE FDA BY THE USER FACILITY. THE REPORT STATED THAT THE DATE OF EVENT WAS (B)(6) 2013 AND THE DATE OF THE REPORT WAS (B)(6) 2013. THE FOLLOWING INFORMATION IS THE DESCRIPTION OF THE COMPLAINT/EVENT NOTED IN THE MEDWATCH REPORT: "DURING PREPARATION FOR DEPLOYMENT IT WAS NOTED THAT A SMALL AMOUNT OF COLLAGEN WAS ALREADY OUTSIDE OF THE PRODUCT HOUSING." THE ACI SALES PROFESSIONAL REPORTED ON (B)(6) 2013 THAT THE MANAGER OF THE SPECIALS DEPARTMENT INFORMED HIM THAT FOLLOWING A PERIPHERAL CATHETERIZATION PROCEDURE THE PHYSICIAN SELECTED A MYNX CADENCE VASCULAR CLOSURE DEVICE 5F FOR CLOSURE. WHEN THE STAFF OPENED THE DEVICE FROM THE PACKAGING, THE SEALANT WAS "DANGLING LOOSE ON THE WIRE OUTSIDE OF THE SEALANT SLEEVE OF THE DELIVERY SYSTEM". THE DEVICE WAS NOT USED. IT IS UNKNOWN HOW HEMOSTASIS WAS ACHIEVED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293731 MYNX CADENCE VASCULAR CLOSURE DEVICE 5F MGB MGB ACCESSCLOSURE, INC. MX5001 F1233802

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR