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

Catalog Number	MX5060
Medical Device Problem Code	Therapy Delivered to Incorrect Body Area (1508)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot: f2601504 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, it appears there was a partial intravascular deployment when using a 5f mynx control vascular closure device (vcd).The device is not being returned for evaluation.
Additional Manufacturer Narrative
As reported, it appears there was a partial intravascular deployment when using a 5f mynx control vascular closure device (vcd).Additional information was requested but not provided.The device was not returned for analysis.A product history record (phr) review of lot f2601504 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported event of ¿sealant inaccurate placement (intravascular)¿ could not be observed as the device was not returned for analysis and procedural images were not provided.The exact cause of the issue experienced by the customer could not be determined.Based on the limited information available for review, vessel characteristics (which were not provided) and procedural/handling factors may have contributed to the intravascular deployment reported since a lesion/stenosis at the access site may prevent proper placement of the balloon, resulting in improper placement of the sealant.Although not intended as a mitigation of risk, the information for safety within the instructions for use (ifu) is provided in the product¿s labeling with the intent to make the user aware of the risks.As stated in the ifu, ¿the safety and effectiveness of mynx have not been established in the following patient populations: patients with clinically significant peripheral vascular disease in the vicinity of the puncture.¿ as warned in the ifu, ¿in addition to the complications noted in the mynx clinical trial, the following potential complications, which may be related to the endovascular procedure or the vascular closure, may occur: allergic reaction, ecchymosis, superficial vein thrombosis, foreign body/local reaction, retroperitoneal bleed, vessel occlusion, pulmonary embolism, or death.¿ additionally, the ifu states, ¿while maintaining tension press button #1 until it is fully aligned with the handle, and the clock symbol is visible in the tension indicator window.This deploys and compresses the sealant against the arteriotomy.¿ neither the phr review, nor the available information suggests that the reported failure could be related to the design or manufacturing process of the unit.Therefore, no corrective/preventive actions will be taken at this time.

• 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 ; 7863138372
• MDR Report Key: 24586584
• Report Number: 3004939290-2026-00273
• Device Sequence Number: 20264889
• Product Code: MGB
• UDI-Device Identifier: 20862028000424
• UDI-Public: (01)20862028000424(17)280115(10)F2601504
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): Unknown
• 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): 04/13/2026

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: MX5060
• Device Lot Number: F2601504
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Supplement Date Received by Manufacturer: 04/12/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2026
• 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.
• Patient Sex: Unknown