BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX CADENCE VASCULAR CLOSURE DEVICE 6/7F

    MDR report key: 2853110 · Received July 10, 2012

    Report

    Report Number
    3004939290-2012-00197
    Event Type
    Injury
    Date Received
    July 10, 2012
    Date of Event
    February 23, 2012
    Report Date
    June 11, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 ROOT CAUSE COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (LOT F1133902) 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 VASCULAR CLOSURE SPECIALIST THAT A PT UNDERWENT A CATHETERIZATION PROCEDURE ON (B)(6) 2012 AT 12:41. ACCESS WAS OBTAINED AT THE RIGHT FEMORAL ARTERY. FOLLOWING THE PROCEDURE, THE PHYSICIAN SELECTED THE MYNX CADENCE VASCULAR CLOSURE DEVICE 6/7F TO CLOSE THE ACCESS SITE. AT 13:02 THE DEVICE WAS DEPLOYED. MANUAL PRESSURE WAS APPLIED FOR 15 MINS FOR HEMOSTASIS. THE PT'S RIGHT GROIN WAS DOCUMENTED AS UNREMARKABLE AND WITH NO BLEEDING. AT 13:28 A FEMOSTOP WAS APPLIED AT THE RIGHT GROIN, AT PRESSURE 60. AT 13:53 THE PT WAS TRANSFERRED TO THE CVICU ROOM. THE FEMOSTOP PRESSURE WAS DECREASED TO 50 AND THE PT'S GROIN SITE BEGAN TO BLEED. PRESSURE WAS HELD AT THE ACCESS SITE. THE PT'S SYS BP DROPPED TO 70'S. AN IV BOLUS WAS GIVEN TO PT. A CT SCAN WAS ORDERED AND BLOOD TRANSFUSION WAS ORDERED. SYS BP WAS 110 AT 14:05. SYS BP WAS 159 AT 14:20 AND 124 AT 15:50. THE PT RECEIVED 4 U PRBCS BETWEEN (B)(6) 2012. A CT SCAN ON (B)(6) INDICATED AN ACUTE HEMATOMA PROX R THIGH 11.8 X 3.1 X 11.5 CM AND NO RETROPERITONEAL HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX CADENCE VASCULAR CLOSURE DEVICE 6/7F MGB ACCESSCLOSURE, INC. MX6701 F1133902

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention JANUVIA| ASA| HEPARIN| INTEGRILLIN