BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP

    MDR report key: 25334161 · Received May 29, 2026

    Report

    Report Number
    3004939290-2026-00643
    Event Type
    Malfunction
    Date Received
    May 29, 2026
    Date of Event
    May 6, 2026
    Report Date
    May 29, 2026
    Manufacturer
    CORDIS US CORP.
    Product Code
    MGB
    UDI-DI
    10862028000410
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS AVAILABLE FOR ANALYSIS, BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 0

    AS REPORTED, ONE 6/7F MYNXGRIP VASCULAR CLOSURE DEVICE (VCD) WAS USED FOR PUNCTURE-SITE CLOSURE AFTER CAROTID ANGIOGRAPHY VIA RETROGRADE FEMORAL ARTERY PUNCTURE. THE CLOSURE HEMOSTASIS DEVICE WAS PREPARED AND OPERATED ACCORDING TO THE CORRECT STEPS, BUT IN THE FINAL STEP, AFTER PINCHING THE WHITE TUBE AND ASPIRATING/DEFLATING THE BALLOON, IT COULD NOT BE WITHDRAWN SMOOTHLY. THEREFORE, THE ENTIRE DEVICE WAS WITHDRAWN, AND PUNCTURE-SITE OOZING WAS MANAGED WITH MANUAL COMPRESSION. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEPLOYER WAS MYNX CERTIFIED. THE DEVICE WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), AND NO ANOMALIES WERE NOTED PRIOR TO USE. THERE WAS NO DIFFICULTY WAS NOTED DURING PREPARATION. THE DEVICE STORAGE TEMPERATURE DID NOT EXCEED 25 °C. THERE WAS NO SIGNIFICANT RESISTANCE OR EXCESSIVE FORCE APPLIED DURING SHUTTLING DOWN, AND THE ADVANCER TUBE WAS ENGAGED OR VISIBLE. NO UNUSUAL FORCE WAS APPLIED WHEN RETRACTING THE SHEATH, AND NO KINKS IN THE SHEATH OR DEVICE WERE OBSERVED AFTER REMOVAL. THE SHEATH INTRODUCER USED WAS A 6F CORDIS AVANTI. THE VESSEL TYPE WAS ARTERIAL, WITH THE VESSEL DIAMETER VERIFIED TO BE GREATER THAN OR EQUAL TO 5 MM, AND THE ANGLE OF ACCESS WAS BETWEEN 30 AND 45 DEGREES. THE PATIENT¿S BMI WAS NOT GREATER THAN 40 KG/M². VESSEL TORTUOSITY WAS LITTLE, WITH NO PRESENCE OF PERIPHERAL VASCULAR DISEASE (PVD), CALCIUM, OR SCAR TISSUE AT THE PUNCTURE SITE. FINGERTIP COMPRESSION WAS MAINTAINED ON THE SKIN DURING DEVICE REMOVAL. BLEEDING WAS NOTED APPROXIMATELY 2¿3 SECONDS AFTER SEALANT DEPLOYMENT/DEVICE REMOVAL, AND THE SEALANT WAS NOT STUCK TO DEVICE COMPONENTS. THE DEVICE WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468508 MYNXGRIP DEVICE, HEMOSTASIS, VASCULAR MGB CORDIS US CORP. F2516901 10862028000410

    Patients

    Seq Age Sex Outcome Treatment
    1