BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX CADENCE VASCULAR CLOSURE DEVICE

    MDR report key: 2131795 · Received June 16, 2011

    Report

    Report Number
    3004939290-2011-00127
    Event Type
    Injury
    Date Received
    June 16, 2011
    Report Date
    May 6, 2011
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. THE REVIEW OF THE LHR (LOT F1105402) DID NOT EXHIBIT ANY ISSUE THAT SUGGESTS THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI SALES PROFESSIONAL THAT A PATIENT UNDERWENT AN ANTEGRADE PERIPHERAL INTERVENTION PROCEDURE ON AN UNKNOWN DATE (EXACT TIMEFRAME NOT PROVIDED). ACCESS WAS OBTAINED AT THE COMMON FEMORAL ARTERY VIA A 6F PROCEDURAL SHEATH WITH ANGIOMAX ON BOARD. THERE IS NO REPORT OF FEMORAL ANGIOGRAM TO ASSESS THE SUITABILITY OF CLOSURE. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS A TRAINED USER OF THE MYNX, CHOSE THE DEVICE FOR FEMORAL ARTERY CLOSURE. IT WAS REPORTED THAT IMMEDIATELY FOLLOWING THE CLOSURE, THE PATIENT DEVELOPED A 4CM HEMATOMA AT THE ACCESS SITE. MANUAL COMPRESSION WAS HELD FOR 35 MINUTES WHICH RESOLVED THE HEMATOMA AND HEMOSTASIS WAS SUCCESSFULLY ACHIEVED. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS AMBULATED AND DISCHARGED TO HOME THE SAME DAY WITH NO REPORTED CLINICAL SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX CADENCE VASCULAR CLOSURE DEVICE MGB MGB ACCESSCLOSURE, INC. MX6701 F1105402

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ANGIOMAX