MAUDE Adverse Event Report: CORDIS US. COR MYNX CONTROL VENOUS; DEVICE, HEMOSTASIS, VASCULAR

Catalog Number	MX61260
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, after passing the distal tip of a 6f-12f mynx control venous vascular closure device (vcd) through a non-cordis sheath valve and advancing the device past the balloon, the sealant sleeve split exposing the mynx control venous sealant.The physician stopped advancing the device, retracted the device, and completely removed the device from the sheath and patient without issue.The physician then used a different mynx control venous vcd to successfully close the patient¿s femoral venous access site.There was no patient harm or reported patient injuries.The device was to close the patient¿s femoral venous access site after completion on an ablation procedure.The device was stored and prepared according to the instructions for use (ifu).A retrograde approach was utilized during the procedure, and the deployer was trained on the mynx device.The femoral artery¿s suitability was verified on venography, including the appropriate insertion angle of the vascular sheath introducer, and the vessel diameter was confirmed to be greater than or equal to 5 mm.The device was removed from the package by having the circulating nurse open the outer package, after which the scrub technician removed the device tray by hand and placed it on the sterile table.The sheath was not kinked or bent upon removal, there was no visible bending or damage to the distal end of the balloon shaft, and no excess force was applied during insertion.The device will not be returned for evaluation.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot: f2607106 presented no issues during the manufacturing process that can be related to the reported event.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. COR; 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, florida 33014 ; 7863138372
• MDR Report Key: 25349637
• Report Number: 3004939290-2026-00650
• Device Sequence Number: 10751262
• Product Code: MGB
• UDI-Device Identifier: 10705032090278
• UDI-Public: (01)10705032090278(17)280313(10)F2607106
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2026

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: MX61260
• Device Lot Number: F2607106
• 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: 05/07/2026
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 06/01/2026
• Supplement Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TERUMO PINNACLE SHEATH.
• Patient Sex: Unknown