BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX CONTROL

    MDR report key: 25017853 · Received April 28, 2026

    Report

    Report Number
    3004939290-2026-00491
    Event Type
    Malfunction
    Date Received
    April 28, 2026
    Date of Event
    January 30, 2026
    Report Date
    April 30, 2026
    Manufacturer
    CORDIS US CORP.
    Product Code
    MGB
    UDI-DI
    20862028000448
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE HAS BEEN ANALYZED BUT THE FINAL, APPROVED DRAFT OF THE ENGINEERING REPORT AND ITS CONCLUSION IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 0

    AS REPORTED, THE ATRAUMATIC TIP OF A 5F MYNX CONTROL VASCULAR CLOSURE DEVICE (VCD) DID NOT ENTER THE SHEATH. THE PRODUCT WAS NO AVAILABLE AND MANUAL COMPRESSION WAS PERFORMED FOR 20 MINUTES TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS PREPARED AND USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU), THERE WERE NO VISIBLE SIGNS OF DEVICE OR PACKAGE DAMAGE PRIOR TO USE. THE DEVICE WAS USED DURING A TRANSFEMORAL CEREBRAL ANGIOGRAPHY (TFCA) PROCEDURE VIA A RETROGRADE FEMORAL APPROACH. THE FEMORAL ARTERY¿S SUITABILITY WAS VERIFIED ON ANGIOGRAPHY, INCLUDING THE INSERTION ANGLE (30~45 DEGREES) OF THE VASCULAR SHEATH INTRODUCER. THE SHEATH WAS NOT KINKED OR BENT UPON REMOVAL. EXCESS FORCE WAS NOT APPLIED DURING INSERTION. THE ACCESS SITE VESSEL WAS NOT TORTUOUS. THE PATIENT¿S BODY MASS INDEX WAS NOT GREATER THAN 40 KG/M². THE VESSEL DIAMETER WAS VERIFIED TO BE GREATER THAN 5MM IN DIAMETER. THE PUNCTURE SITE DID NOT HAVE VISIBLE CALCIUM/PLAQUE. THERE WAS NO STENT NEAR THE PUNCTURE SITE. THE VESSEL DID NOT HAVE STENOSIS >50% AT THE PUNCTURE SITE. THE TARGET FEMORAL SITE WAS NOT PREVIOUSLY CLOSED WITH ANY CLOSURE LESS THAN 30 DAYS PRIOR TO THIS PROCEDURE. THERE WAS NO EVIDENCE OF PRE-EXISTING HEMATOMA, ARTERIOVENOUS FISTULA, OR PSEUDOANEURYSM AT THE ACCESS SITE PRIOR TO USE MYNX CONTROL. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: PER PE FINDINGS, THE SEALANT WAS PRESENT IN MANUFACTURING POSITION PARTIALLY EXPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6045 MYNX CONTROL DEVICE, HEMOSTASIS, VASCULAR MGB CORDIS US CORP. NA F2520904 20862028000448

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown