MAUDE Adverse Event Report: CORDIS US. CORP MYNX CONTROL; DEVICE, HEMOSTASIS, VASCULAR

Catalog Number	MX5060
Medical Device Problem Codes	Image Orientation Incorrect (1305); Premature Activation (1484); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, while trying to deploy a 5f mynx control vascular closure device (vcd), button 1 would not depress even though the tension indicator was lined up.Several attempts to release the tension were made in order to try and reposition the lines; however, the line got stuck and would not move back to the starting position.Button 1 would not depress at all which did not allow the sealant to be delivered, and the sealant eventually was stuck on the end of the unknown sheath.Additionally, damage was noted to the sealant sleeve, which appeared flared and crumbled.The mynx control vcd and unknown 5f sheath were removed and manual compression was held for 30 minutes.There were no reported injuries to the patient.The device was stored and prepared according to the instructions for use (ifu), and it was used during a carotid angiogram procedure.The deployer was trained on the mynx device.The femoral artery¿s suitability was verified on angiography, including the appropriate insertion angle, and the vessel diameter was confirmed to be at least 5 mm, with no vessel tortuosity or presence of peripheral vascular disease or calcium near the puncture site.No damage was noted to the button.The device storage temperature did not exceed 25°c, and no kinks were observed in the sheath or device after removal.The device will be returned for evaluation.
Additional Manufacturer Narrative
This device is available for analysis, but the engineering report 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.

• 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, california 95054 ; 7863138372
• MDR Report Key: 24591358
• Report Number: 3004939290-2026-00286
• Device Sequence Number: 8933028
• Product Code: MGB
• UDI-Device Identifier: 20862028000424
• UDI-Public: (01)20862028000424(17)280107(10)F2600505
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2026

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
• Device Catalogue Number: MX5060
• Device Lot Number: F2600505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2026
• 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: 02/18/2026
• Supplement Date Received by Manufacturer: 04/26/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2026
• 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: UNKNOWN 5F SHEATH
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White