BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX CONTROL VENOUS

    MDR report key: 20106451 · Received August 30, 2024

    Report

    Report Number
    3004939290-2024-00464
    Event Type
    Injury
    Date Received
    August 30, 2024
    Date of Event
    August 5, 2024
    Report Date
    September 16, 2024
    Manufacturer
    CORDIS US CORP.
    Product Code
    MGB
    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

    ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 0

    AS REPORTED, THE BALLOON OF A 6F-12F MYNX CONTROL VENOUS VASCULAR CLOSURE DEVICE (VCD) PULLED THROUGH THE ACCESS SITE. MANUAL COMPRESSION WAS HELD. THE DOCTOR PLACED A STITCH INTO THE ACCESS SITE; A FIGURE 8 SUTURE WAS PLACED TO CLOSE THE ACCESS SITE. IT HAD NOTHING TO DO WITH THE MYNX FAILURE. THE PHYSICIAN CLOSED THE ACCESS SITE WITH SUTURE THEN PRESSURE WAS HELD. THERE WAS NO REPORTED PATIENT INJURY. A RETROGRADE APPROACH WAS USED. THE PATIENT WAS NOT THIN. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN, UNAVAILABLE, NOT ANSWERED, OR NOT APPLICABLE. THE DEVICE WAS NOT SAVED FOR EVALUATION. THE REPORTED EVENT OF ¿BALLOON PULL THROUGH¿ COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE OF THE PULL THROUGH EXPERIENCED COULD NOT BE DETERMINED. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE ISSUE REPORTED. HOWEVER, PREPPING AND HANDLING FACTORS ARE POSSIBLE. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), WHICH IS NOT INTENDED AS A MITIGATION, USERS ARE INSTRUCTED TO PURGE THE DEVICE OF AIR BY DRAWING VACUUM WITH 2-3 ML OF STERILE SALINE PRIOR TO USE. WHILE IN USE, THE USER IS INSTRUCTED TO PULL LIGHTLY ON THE DEVICE HANDLE TO ENSURE THE BALLOON IS ABUTTING THE VESSEL WALL DURING DEPLOYMENT. FAILURE TO COMPLETELY PURGE THE DEVICE OF AIR DURING THE PREP PHASE ALONG WITH EXCESSIVE TENSION APPLIED TO THE DEVICE DURING PULLBACK CAN CAUSE THE BALLOON TO PARTIALLY COLLAPSE AS THE AIR IN THE SYSTEM IS EXPOSED TO ADDITIONAL COMPRESSIVE FORCES. THE COLLAPSED BALLOON CAN THEN BE PULLED THROUGH THE VENOTOMY, RESULTING IN REMOVAL OF THE DEVICE AND ACCESS. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, THERE IS NO INDICATION THAT THE REPORTED EVENT COULD BE RELATED TO THE DESIGN OR MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE/PREVENTATIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    AS REPORTED, THE BALLOON OF A 6F-12F MYNX CONTROL VENOUS VASCULAR CLOSURE DEVICE (VCD) PULLED THROUGH THE ACCESS SITE. THE DOCTOR PLACED A STITCH INTO THE ACCESS SITE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS NOT SAVED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1356410 MYNX CONTROL VENOUS DEVICE, HEMOSTASIS, VASCULAR MGB F2411701

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention