BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX CADENCE VASCULAR CLOSURE DEVICE 6/7F

    MDR report key: 2853126 · Received July 10, 2012

    Report

    Report Number
    3004939290-2012-00195
    Event Type
    Injury
    Date Received
    July 10, 2012
    Date of Event
    February 27, 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

    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. A REVIEW OF THE LHR WAS POSSIBLE AS THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI VASCULAR CLOSURE SPECIALIST THAT A PT UNDERWENT A LEFT FEMORAL ARTERY CATHETERIZATION PROCEDURE ON (B)(6) 2012 AT 09:20. ACCESS WAS OBTAINED AT THE LEFT FEMORAL ARTERY. THE PT WAS ANTICOAGULATED WITH ASA, AND ANGIOMAX. THE SHEATH WAS SUTURED IN AT 10:15 IN THE CVICU. AT 13:05 THE SHEATH WAS PULLED AND PRESSURE WAS APPLIED (DURATION UNK). THE PT'S LEFT GROIN SITE WAS DOCUMENTED AS UNREMARKABLE FROM 09:51 UNTIL 13:30. AT 13:30 A HEMATOMA DESCRIBED AS APPROX 5 CM WAS NOTED. AT 13:34 THE HEMATOMA WAS APPROX 15 CM, MANUAL PRESSURE WAS APPLIED FOR 30 MINS. AT 13:42 SYS BP 89. ATROPINE 0.5 WAS ADMINISTERED. AT 15:00 A FEMOSTOP WAS APPLIED AT ACCESS SITE WITH PRESSURE 60. THE FEMOSTOP WAS REMOVED AT 19:15. THERE IS NO DOCUMENT OF THE GROIN SITE AFTER THAT. ON (B)(6) 2012, (B)(6) INDICATED A PSEUDOANEURYSM 1.6 X 2.3 CM IN THE LEFT FCA. ON (B)(6) 2012, A CT SCAN INDICATED LG ON THE LEFT GROIN, AND A HEMATOMA (NOT A RETROPERITONEAL HEMATOMA). ON (B)(6) 2012 (B)(6) INDICATED EXTENSIVE DVT ON BOTH LEGS AND LG HEMATOMA. THE PSEUDOANEURYSM WAS NOT VISIBLE. THE SURGERY CONSULT. ON (B)(6) 2012, FIRMNESS INCREASED IN THE PT'S LEFT GROIN. PRESSURE WAS HELD FOR 50 MINS, UNTIL THE SKIN TURNED SOFT. ON (B)(6) 2012, IVC FILTER PLACEMENT AND REPAIR OF PT'S LEFT GROIN PUNCTURE SITE. THE 6 U PRBC'S WERE GIVEN BETWEEN (B)(6) 2012.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ASA| ATROPINE| JANUAVIA| ANGIOMAX