BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX CADENCE VASCULAR CLOSURE DEVICE 6/7F

    MDR report key: 2853113 · Received July 10, 2012

    Report

    Report Number
    3004939290-2012-00198
    Event Type
    Injury
    Date Received
    July 10, 2012
    Date of Event
    February 24, 2012
    Report Date
    June 11, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INFO PROVIDED, THE CAUSE OF THE REPORTED EVENT 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 AN R AND L CATHETERIZATION PROCEDURE ON (B)(6) 2012 AT 15:52. ACCESS WAS OBTAINED AT THE RIGHT FEMORAL VEIN AND RIGHT FEMORAL ARTERY. THE PT'S BLOOD PRESSURE WAS ELEVATED TO 182/90 AT THE END OF THE PROCEDURE 16:00. THE 20 MG OF NORMADYNE WAS GIVEN TO THE PT BY IV AT 16:03 AND 16:13. THE PT'S BLOOD PRESSURE WERE DOWN TO 152/79 BY 16:15. FOLLOWING THE PROCEDURE, THE PHYSICIAN SELECTED THE MYNX CADENCE VASCULAR CLOSURE DEVICE 6/7F TO CLOSE THE ACCESS SITE. THE CLOSURE DEVICE WAS DEPLOYED AT 16:17. THE MANUAL PROCEDURE WAS APPLIED TO THE VENOUS SITE FOR 5 MINS FOR HEMOSTASIS. AT 16:25 THE PT'S RIGHT GROIN SITE WAS DOCUMENTED AS UNREMARKABLE. AT 16:35 A HEMATOMA WAS NOTED, IN WHICH TIME MANUAL PRESSURE WAS HELD. AT 16:45 THE HEMATOMA LOOKED IMPROVED, AND MANUAL PRESSURE WAS HELD. AT 16:55 THE HEMATOMA WAS GONE, AND THE ACCESS AREA LOOKED BRUISED. AT 17:10 THE PT'S RIGHT GROIN WAS DESCRIBED AS SOFT. THERE WAS NO CHANGE IN THE PT'S RIGHT GROIN SITE FOR THE REMAINDER OF THE HOSPITAL STAY. AT 18:45 THE PT WAS ADMITTED TO THE CTU FOR OBSERVATION. ON (B)(6) 2012 AT 12:37 THE PT WAS DISCHARGED HOME. THE PT DID NOT RECEIVE ANY BLOOD TRANSFUSION.

    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 Unknown Life Threatening| R ASA| NORMADYNE| NORMADYNE| ASA