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

Catalog Number	MX5060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the sealant of a 5f mynx control vascular closure device (vcd) achieved hemostasis, but bleeding occurred upon ambulation.Manual compression was applied for 5 minutes, and a non-cordis hemostatic device was placed, achieving hemostasis.There was no reported patient injury.The patient was transferred to the post-anesthesia care unit (pacu), where shadowing was noted before ambulation.Additional pressure was applied, and bleeding was observed when the patient walked after 2 hours of bed rest.At a follow-up appointment the following week, bruising was noted from the groin to the knee.The activated clotting time during the procedure was 284.There was no evidence of a pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site before use of the device.There were 2 sheath exchanges and 2 access attempts before intravascular access was achieved.The puncture site was not above the most inferior border of the inferior epigastric artery and was not below the bifurcation.The device was stored and prepared according to the instructions for use (ifu).The device was used during an interventional procedure with a retrograde approach.The deployer was in training with the mynx device.Femoral artery suitability, including the vascular sheath introducer insertion angle, was verified by angiography, and the vessel diameter was verified to be at least 5 mm.The access location was the common femoral artery, and there was no peripheral vascular disease or calcium near the puncture site.The device will not be returned for evaluation.
Additional Manufacturer Narrative
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, florida 33014
• Manufacturer (Section G): Cordis US Corp.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 5452 betsy ross drive; miami lakes, california 95054
• MDR Report Key: 50116372
• Report Number: 3004939290-2026-01030
• Device Sequence Number: 5305126
• Product Code: MGB
• UDI-Device Identifier: 20862028000424
• UDI-Public: (01)20862028000424(17)280508(10)18582810
• Combination Product (Y/N): N
• 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): 08/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: MX5060
• Device Lot Number: 18582810
• 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: 07/08/2026
• Supplement Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2026
• 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: n/a.
• Patient Sex: Male
• Patient Weight: 189 LB