BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX CADENCE VASCULAR CLOSURE DEVICE 6/7F

    MDR report key: 2853089 · Received July 18, 2012

    Report

    Report Number
    3004939290-2012-00220
    Event Type
    Injury
    Date Received
    July 18, 2012
    Date of Event
    June 10, 2012
    Report Date
    June 18, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO ACI FOR INVESTIGATION. BASED ON THE RESULTS OF THE INVESTIGATION, THE REPORTED FAILURE TO DEPLOY COULD NOT BE CONFIRMED. HOWEVER, THE DEVICE APPEARS TO HAVE BEEN MANIPULATED BY THE USER, WHICH WOULD HAVE CAUSED THE SEALANT TO BE PREMATURELY EXPOSED. THE ROOT CAUSE OF THE DEVICE COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (LOT F1213501) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE USER FACILITY PURCHASING AGENT THAT AN UNKNOWN PROCEDURE WAS PERFORMED ON (B)(6) 2012. THE REPORTER ONLY KNEW AND REPORTED THE FOLLOWING: "THE MYNX CADENCE DEVICE FAILED. IT DID NOT DEPLOY. THE PHYSICIAN NOTED THAT A HEMATOMA FORMED POST PROCEDURE." THE PURCHASING AGENT REPORTED THAT SHE DID NOT KNOW THE SIZE OF THE HEMATOMA, NOR THE DURATION OF THE MANUAL COMPRESSION IT TOOK TO RESOLVE THE HEMATOMA. ACI REQUESTED THE ACI SALES PROFESSIONAL FOR THE TERRITORY TO VISIT THE FACILITY AND ATTEMPT TO OBTAIN ADDITIONAL INFORMATION REGARDING THE ALLEGED EVENT. THE ACI SALES PROFESSIONAL WAS NOT ABLE TO OBTAIN ANY ADDITIONAL INFORMATION REGARDING THE ALLEGED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX CADENCE VASCULAR CLOSURE DEVICE 6/7F MGB ACCESSCLOSURE, INC. MX6701 F1213501

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other