BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F-7F

    MDR report key: 10246824 · Received July 8, 2020

    Report

    Report Number
    3004939290-2020-01815
    Event Type
    Malfunction
    Date Received
    July 8, 2020
    Date of Event
    June 10, 2020
    Report Date
    July 8, 2020
    Manufacturer
    CORDIS SANTA CLARA
    Product Code
    MGB
    UDI-DI
    10862028000410
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED, THE SEALANT OF THE THREE 6F/7F MYNXGRIP VASCULAR CLOSURE DEVICES (VCD) FAILED TO DEPLOY. THERE WERE NO REPORTED PATIENT INJURIES. THE DEVICES WERE STORED AS PER LABELING AND OPENED IN A STERILE FIELD. HEMOSTASIS WAS ACHIEVED BY ¿MANUAL PRESSURE¿. MANUAL COMPRESSION WAS GREATER THAN 25 MINS. THE PATIENT¿S HOSPITALIZATION WAS EXTENDED, AND PATIENT WAS ADMITTED OVERNIGHT FOR OBSERVATION. THE PATIENT RECOVERED AFTER THE MYNX EVENT. THE USER WAS UNABLE TO SHUTTLE THE DEVICE. THE ADVANCER TUBE WAS NOT VISIBLE. THE DEPLOYER WAS MYNXGRIP CERTIFIED. A NON -CORDIS 7FR SHEATH INTRODUCER WAS USED. THE FEMORAL ARTERY¿S SUITABILITY WAS VERIFIED ON ANGIOGRAPHY OR VENOGRAPHY, INCLUDING THE INSERTION ANGLE (30-45 DEGREES) OF THE VASCULAR SHEATH INTRODUCER. THE VESSEL TYPE WAS ARTERIAL. THE VESSEL DIAMETER WAS VERIFIED TO BE GREATER THAN OR EQUAL TO 5 MM IN DIAMETER. THERE WAS NO VESSEL TORTUOSITY. THERE WAS NO PRESENCE OF PVD / CALCIUM IN THE VICINITY OF THE PUNCTURE SITE. 117220-1: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT F2005902 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. 117220-2: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT F2005902 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. 117220-3: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT F2005902 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE REPORTED ¿SEALANT FAILURE TO DEPLOY¿ COULD NOT BE CONFIRMED IN ANY OF THE DEVICES AS THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE OF THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED. PROCEDURAL FACTORS, SUCH AS AN INCOMPLETE ENGAGEMENT OF THE ADVANCER TUBE DURING THE PROCEDURE, MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. IT SHOULD BE NOTED THAT IF THE SHUTTLE IS NOT ADVANCED UNTIL THE ADVANCER TUBE IS ENGAGED TO THE PROXIMAL TAMP LOCK, THIS WILL CAUSE THE ADVANCER TUBE AND SEALANT TO FOLLOW THE SHUTTLE CARTRIDGE BACK OUT OF THE TISSUE TRACT DURING THE RETRACTION STEP, RESULTING IN THE DEVICE FAILING TO DEPLOY. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), WHICH IS NOT INTENDED AS A MITIGATION OF RISK, IT STATES TO INSERT THE MYNXGRIP INTO THE PROCEDURAL SHEATH UP TO THE WHITE SHAFT MARKER, THEN INFLATE THE BALLOON UNTIL THE BLACK MARKER IS FULLY VISIBLE ON THE INFLATION INDICATOR. NEITHER THE PHR REVIEW NOR THE INFORMATION AVAILABLE FOR REVIEW SUGGESTS THAT THE REPORTED EVENTS COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE/PREVENTATIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED, THE SEALANT OF THE THREE 6F-7F MYNXGRIP VASCULAR CLOSURE DEVICES (VCD) FAILED TO DEPLOY. THE DEVICES WERE STORED AS PER LABELING AND OPENED IN A STERILE FIELD. HEMOSTASIS WAS ACHIEVED BY ¿MANUAL PRESSURE¿. MANUAL COMPRESSION WAS GREATER THAN 25 MINS. THE PATIENT¿S HOSPITALIZATION WAS EXTENDED, AND PATIENT WAS ADMITTED OVERNIGHT FOR OBSERVATION. PATIENT RECOVERED AFTER THE MYNX EVENT. THERE IS NO REPORTED PATIENT INJURY. THE USER WAS UNABLE TO SHUTTLE THE DEVICE. THE ADVANCER TUBE WAS NOT VISIBLE. THE DEPLOYER IS MYNXGRIP CERTIFIED. A NON -CORDIS 7FR SHEATH INTRODUCER WAS USED. THE FEMORAL ARTERY¿S SUITABILITY WAS VERIFIED ON ANGIOGRAPHY OR VENOGRAPHY, INCLUDING THE INSERTION ANGLE (30-45 DEGREES) OF THE VASCULAR SHEATH INTRODUCER. THE VESSEL TYPE IS ARTERIAL. THE VESSEL DIAMETER WAS VERIFIED TO BE GREATER THAN OR EQUAL TO 5 MM IN DIAMETER. THERE WAS NO VESSEL TORTUOSITY. THERE WAS NO PRESENCE OF PVD / CALCIUM IN THE VICINITY OF THE PUNCTURE SITE. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION, IT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712077 MYNXGRIP VASCULAR CLOSURE DEVICE 6F-7F DEVICE, HEMOSTASIS, VASCULAR MGB CORDIS SANTA CLARA MX6721 F2005902 10862028000410

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR