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

Catalog Number	MX6760
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/08/2026
Type of Reportable Event	Death
Event or Problem Description
As reported, a 6/7f mynx control vascular closure device (vcd) was deployed by the physician, and the patient later experienced complications.There was no reported patient injury.The patient had been discharged home before the complications occurred.The physician was notified, and the patient underwent emergency surgery.The patient subsequently expired.The device will 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 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: 50772060
• Report Number: 3004939290-2026-01281
• Device Sequence Number: 13366188
• Product Code: MGB
• UDI-Device Identifier: 10862028000434
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 09/15/2026

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: MX6760
• Device Lot Number: 18598910
• 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: 08/17/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2026
• 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.
• Outcome Attributed to Adverse Event: Death; Life Threatening
• Patient Sex: Unknown