BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX CADENCE VASCULAR CLOSURE DEVICE 5F

    MDR report key: 2840177 · Received June 22, 2012

    Report

    Report Number
    3004939290-2012-00165
    Event Type
    Malfunction
    Date Received
    June 22, 2012
    Date of Event
    May 24, 2012
    Report Date
    May 24, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INFO PROVIDED AND NO RETURNED DEVICE FOR PHYSICAL INVESTIGATION, THE REPORTED EVENT COULD NOT BE CONFIRMED AND THE CAUSE COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (LOT F1211403) INDICATED THAT THE MYNX LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI SALES ASSOCIATE THAT A PT UNDERWENT A DIAGNOSTIC CORONARY PROCEDURE ON (B)(6) 2012. FOLLOWING THE PROCEDURE, THE PHYSICIAN SELECTED THE MYNX CADENCE VASCULAR CLOSURE DEVICE 5F TO CLOSE THE ACCESS SITE. ALLEGEDLY, THE DEVICE DID NOT DEPLOY CORRECTLY. NO OTHER DETAILS COULD BE RECALLED BY THE STAFF. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX CADENCE VASCULAR CLOSURE DEVICE 5F MGB MGB ACCESSCLOSURE, INC. MX5001 F1211403

    Patients

    Seq Age Sex Outcome Treatment
    1