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

Catalog Number	MX61260
Medical Device Problem Codes	Decrease in Pressure (1490); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the balloon of a 6f¿12f mynx control venous vascular closure device (vcd) was found to have a micro hole after the device came out of the body and the balloon was observed to be deflated.The site was sutured, and manual pressure was held for 10 minutes for hemostasis.There was no reported patient injury.The device was prepped per the instructions for use (ifu), advanced through the sheath, and attached around the side port of the sheath.The physician inflated the balloon and viewed the inflation indicator as white, black, and white, and it appeared ready to use.As the physician pulled back the device along with the sheath, the device came out of the body.The balloon was deflated, and the inflation indicator was no longer visible.When the balloon was tested again for inflation, a small stream of saline was observed coming from a micro hole in the balloon.The mynx vascular closure device (vcd) was used in an electrophysiology (ep) ablation procedure with a retrograde approach.The deployer¿s mynx training status was reported as ¿excellent.¿ a cordis avanti 10f sheath was used.Femoral vessel suitability, including the vascular sheath introducer insertion angle of 30¿45 degrees, was verified.The vessel was venous and femoral, and the vessel diameter was verified to be greater than or equal to 5 mm.There was no vessel tortuosity and no peripheral vascular disease (pvd) or calcium in the vicinity of the puncture site.The patient was stable and doing well post-procedure.The mynx vcd was stored and prepped according to the instructions for use (ifu).There was no prior percutaneous transluminal angioplasty (pta), stent, or vascular graft in the common femoral artery or vein.The balloon lost pressure after being pulled to the arteriotomy.The device will 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 VENOUS
• Common Device Name: Device, Hemostasis, Vascular
• Manufacturer (Section D): Cordis US.Corp; 14201 nw 60th 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: 50892866
• Report Number: 3004939290-2026-01338
• Device Sequence Number: 10706541
• Product Code: MGB
• UDI-Device Identifier: 10705032090278
• UDI-Public: (01)10705032090278(17)280101(10)18603372
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/24/2026

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: MX61260
• Device Lot Number: 18603372
• Was Device Available for Evaluation?: Yes
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2026
• 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: 10F Cordis Avanti sheath
• Patient Sex: Unknown