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

Catalog Number	MX61260
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a 6f¿12f mynx control venous vascular closure device (vcd) locked out, and the tension indicator line would not move despite the device being pulled all the way to the venotomy during an atrial fibrillation ablation procedure.The device could not be deployed.The balloon was deflated, and manual pressure was held for approximately 8 minutes.There was no reported patient injury.Access was obtained through the left and right femoral veins.The left femoral vein had 2 access sites, 10f and 7f, approximately 6mm apart.A mynx control venous vascular closure device was deployed at the 10f site without issue before the reported event.The reported issue occurred at the 7f left femoral vein access site.A mynx control venous vascular closure device was subsequently deployed at an 8f left femoral vein access site without issue.Protamine 100mg was administered.No oozing was observed at the site, and the patient remained in recovery per bedrest protocol.No damage was found on the device or device packaging prior to opening.The mynx vascular closure device (vcd) was used in an interventional atrial fibrillation (afib) ablation electrophysiology (ep) case using an antegrade approach.The deployer was mynx certified.A 7f avanti+ sheath was used.Femoral vessel suitability, including an insertion angle of 30¿45 degrees, was verified on venography.The vessel was the left femoral vein, 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.Hemostasis was achieved with manual compression for 3 minutes.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 VENOUS
• Common Device Name: Device, Hemostasis, Vascular
• Manufacturer (Section D): Cordis US Corp.; 14201 nw 60 avenue; miami lakes, florida 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: 50856874
• Report Number: 3004939290-2026-01323
• Device Sequence Number: 21338563
• Product Code: MGB
• UDI-Device Identifier: 10705032090278
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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): 09/22/2026

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: 18609188
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/10/2026
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2026
• 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: 7F Avanti+ sheath; Medtronic Affera AF Ablation
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Race: White