BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX CADENCE VASCULAR CLOSURE DEVICE 5F

    MDR report key: 2840194 · Received June 28, 2012

    Report

    Report Number
    3004939290-2012-00175
    Event Type
    Malfunction
    Date Received
    June 28, 2012
    Date of Event
    May 24, 2012
    Report Date
    May 30, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED DEVICE AT HIGH MAGNIFICATION CONFIRMED THAT THE SOURCE OF THE LEAK WAS A LONGITUDINAL TEAR IN THE BALLOON, APPROXIMATELY 5 MM FROM THE BALLOON PROXIMAL TIP. NO OTHER SOURCE OF A LEAK WAS IDENTIFIED. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE TEAR COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (LOT F1210103) INDICATED THAT THE MYNX LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT. SEE MEDWATCH REPORT 3004939290-2012-00173 & 3004939290-2012-00174 FOR THE SECOND AND THIRD DEVICE USED IN THIS PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI VASCULAR CLOSURE SPECIALIST THAT A FEMALE PT UNDERWENT A DIAGNOSTIC CORONARY PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED AT THE SFA VIA A 5F SHEATH (MODEL UNKNOWN). A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED NO PVD/CALCIUM IN THE VICINITY OF THE ACCESS SITE. FOLLOWING THE PROCEDURE, THE DEPLOYER SELECTED THE MYNX CADENCE VASCULAR CLOSURE DEVICE 5F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE DEVICE WAS INSERTED INTO THE PT AND THE BALLOON LOST PRESSURE DURING PULL BACK, WHEN THE DEPLOYER REACHED THE TIP OF THE SHEATH. THE DEPLOYER REMOVED THE DEVICE AND SINCE ACCESS WAS NOT LOST, THE DEPLOYER PREPPED AND DEPLOYED A SECOND MYNX CADENCE VASCULAR CLOSURE DEVICE 5F. THE SECOND DEVICE BALLOON LOST PRESSURE DURING PULL BACK, WHEN THE DEPLOYER REACHED THE TIP OF THE SHEATH. THE DEPLOYER REMOVED THE SECOND DEVICE AND SINCE ACCESS WAS MAINTAINED A THIRD MYNX CADENCE VASCULAR CLOSURE DEVICE 5F WAS PREPPED AND DEPLOYED. THE BALLOON FROM THE THIRD DEVICE ALSO LOST PRESSURE DURING PULL BACK, WHEN THE DEPLOYER REACHED THE TIP OF THE SHEATH. THE DEPLOYER REMOVED THE THIRD DEVICE FROM THE PT. THE SHEATH REMAINED IN PLACE, AND THE PT WAS TRANSFERRED FROM THE CATH LAB AND THE SHEATH WAS REMOVED USING MANUAL PRESSURE (MINUTES UNKNOWN). HEMOSTASIS WAS ACHIEVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX CADENCE VASCULAR CLOSURE DEVICE 5F MGB, PRODUCT CODE: MGB MGB ACCESSCLOSURE, INC. MX5001 F1210103

    Patients

    Seq Age Sex Outcome Treatment
    1