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

Catalog Number	MX6760
Medical Device Problem Codes	Decrease in Pressure (1490); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the balloon of a 6f/7f mynx control vascular closure device (vcd) popped when attempting to deploy the device.Manual compression was applied.There was no reported patient injury.The physician believed the failure was due to the anatomy and calcium.No patient harm occurred, and hemostasis was achieved with manual compression.A retrograde approach was used.The deployer was trained and described as a long-time supporter.Calcium was present however the severity was unknown.The balloon reportedly popped during deployment while inside the patient when attempting to position/deploy the device.Based on the physician¿s description, the balloon popped while attempting deployment; it was believed to have occurred after pullback to the arteriotomy, although this could not be definitively confirmed.The device was not retained for return evaluation.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: 50668576
• Report Number: 3004939290-2026-01242
• Device Sequence Number: 15990739
• Product Code: MGB
• UDI-Device Identifier: 10862028000434
• UDI-Public: (01)10862028000434(17)280415(10)F2610503
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 09/15/2026

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: F2610503
• 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: 08/13/2026
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/08/2026
• Supplement Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2026
• 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