BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE

    MDR report key: 3945153 · Received July 18, 2014

    Report

    Report Number
    3004939290-2014-00094
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 20, 2014
    Report Date
    July 2, 2014
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INFORMATION PROVIDED AND NO RETURNED DEVICE FOR PHYSICAL INVESTIGATION, THE REPORTED EVENT COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE LHR WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE IN-PATIENT UNDERWENT A DIAGNOSTIC CATHETERIZATION PROCEDURE ON (B)(6) 2014 WITH A 5F SHEATH. IT WAS DISCOVERED THAT THE PATIENT NEEDED FURTHER TREATMENT AND WAS TRANSFERRED TO ANOTHER PHYSICIAN FOR INTERVENTION. THE SHEATH WAS UPSIZED TO A SHORT 6F SHEATH. ANGIOMAX AND BRILINTA WERE ADMINISTERED FOR ANTI-COAGULATION. AFTER THE INTERVENTION, A GROIN ANGIOGRAM WAS TAKEN AND IT WAS NOTED THAT THERE WAS EVIDENCE OF CALCIUM IN THE AREA OF THE ARTERIOTOMY IN THE COMMON FEMORAL ARTERY. THE DECISION TO CLOSE THE ACCESS SITE WITH A MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE WAS MADE BY THE PHYSICIAN. THE TECHNICIAN WHO IS A TRAINED MYNX USER PREPPED THE BALLOON AND SUBSEQUENTLY DEPLOYED THE DEVICE PER THE IFU. AFTER APPROXIMATELY 4 MINUTES OF ADJUNCTIVE HOLD, THE TECHNICIAN FELT THAT THERE WAS HEMOSTASIS AND FOLDED A 4X4 GAUZE TWICE, PLACED THE GAUZE ON THE PUNCTURE SITE AND THEN SECURED IT IN PLACE WITH A TEGADERM BANDAGE. THE TECHNICIAN BEGAN TO REMOVE THE DRAPE, COVER THE PATIENT AND CLEAN THE ROOM. AFTER APPROXIMATELY 3 MINUTES, THE PATIENT "CRIED OUT IN PAIN" AND IT WAS DISCOVERED THAT A HEMATOMA THE SIZE OF A SOFTBALL HAD FORMED AT THE AREA WHERE THE ARTERIAL ACCESS WAS OBTAINED. MANUAL COMPRESSION WAS IMMEDIATELY APPLIED, BUT THE HEMATOMA CONTINUED TO GROW EXTENDING DOWN THE PATIENT'S LEG FOR APPROXIMATELY 20 CM. AFTER APPROXIMATELY 45 MINUTES, AN ULTRASOUND WAS PERFORMED AND A PSEUDOANEURYSM WAS DISCOVERED. AN ULTRASOUND WAND WAS USED TO PROVIDE FOCAL COMPRESSION AND AFTER APPROXIMATELY 2.5 HOURS, THE PATIENT WAS SENT TO SURGERY FOR FURTHER INTERVENTION. SOME 600 CC'S OF BLOOD WERE EVACUATED FROM THE SITE AND A STITCH WAS USED TO CLOSE THE ARTERIOTOMY. FURTHERMORE, IT WAS DISCOVERED THAT THERE WAS CALCIFICATION ON THE OUTSIDE OF THE ARTERY AND THE MYNXGRIP SEALANT WAS ON THE SITE BUT DID NOT PROVIDE HEMOSTASIS. THERE WAS NO FURTHER TREATMENT NEEDED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423221 MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE MGB MGB ACCESSCLOSURE, INC. MX6721 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| O| R ANGIOMAX| BRILINTA