BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE

    MDR report key: 5250932 · Received November 25, 2015

    Report

    Report Number
    3004939290-2015-00559
    Event Type
    Injury
    Date Received
    November 25, 2015
    Date of Event
    November 10, 2015
    Report Date
    November 11, 2015
    Manufacturer
    CARDINAL HEALTH
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS COUGHING POST PROCEDURE AND BLOOD PRESSURE WAS 230/140. IT SHOULD BE NOTED THAT THE MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY PATIENT BROCHURE INDICATES THAT "NO VIGOROUS ACTIVITY OR STRAINING.- COUGHING, SNEEZING, OR STRAINING FOR A BOWEL MOVEMENT: SUPPORT YOUR GROIN BY PRESSING WITH YOUR PALM ON TOP OF THE DRESSING/BANDAGE." AS SUCH ACTIVITY MAY RESULT IN A HEMATOMA/BLEED. ADDITIONALLY THE MYNXGRIP INSTRUCTIONS FOR USE (IFU) STATES: "THE SAFETY AND EFFECTIVENESS OF THE MYNX VASCULAR CLOSURE DEVICE HAVE NOT BEEN ESTABLISHED IN THE FOLLOWING PATIENT POPULATIONS: PATIENTS WITH UNCONTROLLED HYPERTENSION (SYSTOLIC BP >180 MM HG)". A REVIEW OF THE LHR WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED BY THE SALES REPRESENTATIVE: AFTER THE MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE WAS DEPLOYED, THE PATIENT WAS TAKEN BACK TO HIS RECOVERY ROOM AT WHICH TIME A HEMATOMA (6 CM IN SIZE OR LESS) DEVELOPED. THE PATIENT WAS COUGHING POST PROCEDURE AND BLOOD PRESSURE WAS 230/140. WHEN THE NURSE FIRST DISCOVERED THE HEMATOMA, MANUAL PRESSURE WAS APPLIED FOR 30 MINUTES OR LESS, BUT SINCE THE PATIENT HAD RECEIVED 10,000 UNITS OF HEPARIN FOR THE INTERVENTIONAL PROCEDURE, THEY CHOSE TO APPLY A FEMOSTOP SO THE NURSE WOULD NOT HAVE TO HOLD PRESSURE. THE SALES REPRESENTATIVE WAS TOLD THE FEMOSTOP HAD MINIMAL PRESSURE APPLIED. THEY JUST DID NOT WANT TO TAKE THE CHANCE THAT A HEMATOMA WOULD RETURN DUE TO THE PATIENT'S HIGH BLOOD PRESSURE. THE PATIENT STAYED OVERNIGHT, PER THE HOSPITAL'S PROTOCOL FOR ALL INTERVENTIONAL PATIENTS AND WAS DISCHARGED THE MORNING OF (B)(6) 2015 WITH NO OTHER ISSUES THAT THE SALES REPRESENTATIVE IS AWARE OF. SHEATH SIZE: 7F PROCEDURE TYPE: INTERVENTIONAL CORONARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780277 MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE MGB MGB CARDINAL HEALTH MX6721 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 10,000 UNITS OF HEPARIN