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	08/25/2026
Type of Reportable Event	Malfunction

• 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 ; 14021 nw 60 avenue; miami lakes, FL 33014 ; +1(786)313-8372
• MDR Report Key: 50834697
• Report Number: 3004939290-2026-01306
• Device Sequence Number: 10069786
• Product Code: MGB
• UDI-Device Identifier: 10862028000434
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/20/2026

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: MX6760
• Device Lot Number: F2610301
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2026
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/13/2026
• 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
• Patient Sex: Female
• Patient Weight: 110 LB