MAUDE Adverse Event Report: Cordis US Corp MYNX CONTROL; Device, Hemostasis, Vascular

Catalog Number	MX6760
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, button 2 of a 6f/7f mynx control vascular closure device (vcd) could be pressed down but would immediately pop back up.There was no reported patient injury.The balloon was filled with a mixture of contrast and saline and observed under x-ray during deployment and balloon deflation.The device was stored and prepared according to the instructions for use (ifu), and no device or package damage was noted prior to use.The device was used in an angiography procedure with intervention using a retrograde approach.The physician was trained on the mynx device.A 5f non-cordis sheath was used.Vessel suitability, including a 30¿45 degree vascular sheath introducer insertion angle, was verified on venography, and the vessel diameter was verified to be at least 5 mm.Hemostasis was achieved with the same mynx device, and sealant deployment was successful; however, button 2 would return to the start position once pressed.The balloon was not inverted.The balloon was observed to inflate and deflate under x-ray guidance with a contrast and saline mixture in the balloon, and no problems with the balloon were reported.The device will not be returned for evaluation.
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.

• Brand Name: MYNX CONTROL
• Common Device Name: Device, Hemostasis, Vascular
• Manufacturer (Section D): Cordis US Corp; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): Cordis US Corp.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 5452 betsy ross drive; santa clara, CA 95054 ; +1(786)313-8372
• MDR Report Key: 50754777
• Report Number: 3004939290-2026-01275
• Device Sequence Number: 9224514
• Product Code: MGB
• UDI-Device Identifier: 10862028000434
• UDI-Public: (01)10862028000434(17)280331(10)F2609003
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P040044
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MX6760
• Device Lot Number: F2609003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2026
• Supplement Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 09/14/2026
• Supplement Report FDA Received Date: 09/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5F Terumo sheath
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Race: White