BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2840287 · Received April 24, 2012

    Report

    Report Number
    3004939290-2012-00091
    Event Type
    Malfunction
    Date Received
    April 24, 2012
    Date of Event
    February 21, 2012
    Report Date
    March 29, 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 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 CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE LHR WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT PROVIDED. SEE MEDWATCH REPORT # 3004939290-2012-00090 FOR THE FIRST DEVICE USED IN THIS PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI SALES PROFESSIONAL THAT A PATIENT UNDERWENT A DIAGNOSTIC PERIPHERAL CATHETERIZATION PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED AT THE SUPERFICIAL FEMORAL ARTERY WITH A 6F SHEATH (MODEL UNKNOWN). A PRE-PROCEDURE FEMORAL ANGIOGRAM REVELED PRESENCE OF PVD/CALCIUM IN THE VICINITY OF THE ACCESS SITE. FOLLOWING THE PROCEDURE, THE PHYSICIAN, WHO IS A TRAINED USER OF THE MYNX, SELECTED THE MYNX VASCULAR CLOSURE DEVICE 6F/7F FOR FEMORAL ARTERIAL CLOSURE. IT WAS REPORTED THAT THE BALLOON LOST PRESSURE PRIOR TO THE ARTERIOTOMY. ACCESS WAS NOT LOST AND A SECOND MYNX DEVICE WAS USED; HOWEVER, THE SECOND MYNX DEVICE ALSO LOST PRESSURE. THE PHYSICIAN CONVERTED THE PATIENT TO 8 MINUTES OF MANUAL COMPRESSION WITH NO FURTHER COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX VASCULAR CLOSURE DEVICE 6F/7F MGB ACCESSCLOSURE, INC. MX6700 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1