BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX CONTROL VENOUS

    MDR report key: 20339548 · Received September 30, 2024

    Report

    Report Number
    3004939290-2024-00541
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Date of Event
    September 5, 2024
    Report Date
    October 3, 2024
    Manufacturer
    CORDIS US CORP
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER ADDITIONAL INFORMATION RECEIVED, THIS EVENT (EVENT: (B)(6)) WILL BE VOIDED AS IT IS A DUPLICATE EVENT. THEREFORE, THE INITIAL FDA REPORT WILL BE UNREPORTED. THE ORIGINAL TRUE EVENT WAS ALREADY SUBMITTED TO FDA VIA REPORT NUMBER: 3004939290-2024-00542.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 0

    AS REPORTED, THE BALLOON ON A 6-12F MYNX CONTROL VENOUS VASCULAR CLOSURE DEVICE (VCD) PULLED THROUGH. HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION. THERE WERE NO REPORTS OF PATIENT INJURY. THERE WERE NO DEVIATIONS FROM THE STANDARD HANDLING AND PREPARATION PROCEDURES FOR THE DEVICE. THE DEVICE WAS INSPECTED FOR ANY VISIBLE DEFECTS PRIOR TO USE. THE MYNX VASCULAR CLOSURE DEVICE (VCD) WAS USED IN AN INTERVENTIONAL PROCEDURE, WHICH EMPLOYED A RETROGRADE APPROACH. THE DEPLOYER WAS MYNX CERTIFIED. THE MYNX VCD WAS PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE BALLOON DID NOT LOSE PRESSURE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1915847 MYNX CONTROL VENOUS DEVICE, HEMOSTASIS, VASCULAR MGB CORDIS US CORP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN.