MYNX CONTROL VENOUS
Received Jul 20, 2026
Report 3004939290-2026-00949 · MDR key 25871463
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Local Reaction
Narrative
Additional Manufacturer Narrative
DUE TO SYSTEM LIMITATIONS, SECTION H6 REQUIRED TO INPUT TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS FOR AN INITIAL REPORT. PENDING ADDITIONAL INFORMATION TO COMPLETE INVESTIGATION. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
Description of Event or Problem
AS REPORTED, THREE 6F¿12F MYNX CONTROL VENOUS VASCULAR CLOSURE DEVICES (VCD) WERE ASSOCIATED WITH GROIN ISSUES WITH POSSIBLE INFECTIONS. THE PHYSICIAN STATED THAT THE PATIENT SENT PHOTOGRAPHS OF THE GROIN SITES FROM HOME, SOME OF WHICH SHOWED DRAINAGE OF PUS. THE PATIENT WAS NOT ASKED TO RETURN FOR EVALUATION, AND THE SITES WERE NOT CULTURED. THE PHYSICIAN TREATED THE PATIENTS WITH ANTIBIOTICS. IT WAS REPORTED THAT THE PATIENTS HAD THREE ACCESS SITES, ALL OF WHICH WERE CLOSED WITH THE MYNX CONTROL VENOUS VASCULAR CLOSURE DEVICE (VCD) ON THE RIGHT GROIN. THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PACKAGING WAS OPENED IN A STERILE FIELD. STERILE TECHNIQUE WAS FOLLOWED. CHLORAPREP WAS USED AT THE BEGINNING OF THE PROCEDURE TO CLEAN THE ACCESS SITE. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE DISCARDED.