BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX CADENCE VASCULAR CLOSURE DEVICE 6/7F

    MDR report key: 2840202 · Received June 22, 2012

    Report

    Report Number
    3004939290-2012-00162
    Event Type
    Malfunction
    Date Received
    June 22, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE AND THE PROCEDURAL SHEATH WERE 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 ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE LHR WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI SALES PROFESSIONAL THAT A PT UNDERWENT A CORONARY PROCEDURE ON AN UNK DATE. FOLLOWING THE PROCEDURE, THE PHYSICIAN, WHO IS IN TRAINING, SELECTED THE MYNX CADENCE VASCULAR CLOSURE DEVICE 6/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT WHEN THE PHYSICIAN PULLED THE BALLOON BACK TO THE ARTERIOTOMY, THE PHYSICIAN PULLED THE BALLOON THROUGH. THE PHYSICIAN APPLIED 10 MINUTES OF MANUAL COMPRESSION TO ACHIEVE HEMOSTASIS. THE PT WAS REPORTED AS FINE. NO FURTHER INFO IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1