BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE

    MDR report key: 3900872 · Received June 27, 2014

    Report

    Report Number
    3004939290-2014-00075
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. A REVIEW OF THE LHR WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. HOWEVER, IT WAS REPORTED THAT THE STICK LOCATION WAS HIGH. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU) WARNINGS INDICATES THE FOLLOWING: "DO NOT USE THE MYNXGRIP VASCULAR CLOSURE DEVICE IF THE PUNCTURE SITE IS LOCATED ABOVE THE MOST INFERIOR BORDER OF THE INFERIOR EPIGASTRIC ARTERY (IEA) AND/OR ABOVE THE INGUINAL LIGAMENT BASED UPON BONY LANDMARKS, SINCE SUCH A PUNCTURE SITE MAY RESULT IN A RETROPERITONEAL HEMATOMA/BLEED."

    Additional Manufacturer Narrative · 1

    OUTCOMES ATTRIBUTED TO ADVERSE EVENT, IS BEING UPDATED TO INCLUDE LIFE-THREATENING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN INTERVENTIONAL PERIPHERAL BILATERAL PROCEDURE ON (B)(6) 2014. THE STICK LOCATION WAS "SO HIGH" THAT IT WAS EITHER AT THE PROXIMAL COMMON FEMORAL ARTERY OR AT THE DISTAL EXTERNAL ILIAC ARTERY. THE VESSEL SIZE WAS NOTED TO BE 6 MM. FOLLOWING THE PROCEDURE, THE TECHNICIAN WHO IS TRAINING TO THE ACI DEVICE, SELECTED A MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE PATIENT HAD A VASOVAGAL EPISODE IMMEDIATELY AFTER THE ILIAC STENTING PROCEDURE AND THE MYNXGRIP DEPLOYMENT. THE PATIENT WAS STILL ON THE TABLE AND THE PHYSICIAN DECIDED TO PERFORM ANOTHER ANGIOGRAM TO SEE IF THE PATIENT WAS HAVING A POST STENT ACTIVE BLEEDING. IT WAS DESCRIBED BY THE PHYSICIAN THAT A RETROPERITONEAL BLEED WAS ARISING FROM THE EXTERNAL ILIAC/COMMON FEMORAL AREA. THE PHYSICIAN FURTHER SAID IT WAS LIKELY TO BE FROM THE MYNXGRIP DEPLOYMENT SITE. THE PHYSICIAN DID TWO SEPARATE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON INFLATIONS AT THE SITE OF THE EXTRAVASATION FOR SEVERAL MINUTES EACH. AFTER THE INFLATIONS, THE PHYSICIAN DETERMINED THE RETROPERITONEAL BLEED HAD BEEN STOPPED. THE PATIENT WAS TO BE GIVEN 2 UNITS OF BLOOD LATER IN THE ICU. THE LEFT ACCESS SITE WAS ONLY VISUALIZED BY AN ANGIOGRAM WITH THE LONG SHEATH IN PLACE, MAKING IT VERY HARD TO VISUALIZE WHERE THE SHEATH INSERTION OR ACCESS SITE WAS. IT WAS NOTED THAT THE PATIENT'S HOSPITALIZATION WAS MYNX RELATED, BUT THE DISCHARGE DATE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376811 MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE MGB MGB ACCESSCLOSURE, INC. MX6721 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R