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

Catalog Number	MX61260
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot: f2605504 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.
Event or Problem Description
As reported, bleeding occurred following use of two 6f¿12f mynx control venous vascular closure device (vcd) at left femoral vein access sites (7f and 11f).Avanti+ 7f and 11f sheaths were used.The procedure was an atrial fibrillation pulsed field ablation, and the device deployment was reported as successful with no issues.The patient was noted to have difficult vascular access.Post-procedure, the patient experienced oozing from both left and right femoral vein access sites as well as intravenous sites and was admitted due to continued/ excessive bleeding.The patient was on antiplatelet therapy, and bleeding continued the following morning after stitch removal from a non-cordis vascular closure device site (right femoral vein), requiring additional bedrest prior to discharge.The procedure was performed using a retrograde approach, and the deployer was mynx certified.Vessel suitability was verified on venography, including insertion angle, and vessel diameter was confirmed to be greater than or equal to 5 mm.There was little vessel tortuosity, and peripheral vascular disease was noted with difficult access.There was no pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site, and no multiple stick attempts were made.The patient was laying flat in bed when bleeding started.The puncture site was neither above the inferior epigastric artery nor below the bifurcation, and there was no posterior wall puncture.Treatment included hospital admission for overnight observation, manual pressure, application of a hemostatic agent, and extended bedrest.The patient was also bleeding from intravenous sites, and brillinta use was considered a contributing factor.There was no hemodynamic instability reported.The device will not be returned for evaluation as the devices were discarded.

• Brand Name: MYNX CONTROL VENOUS
• 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 ; 7863138372
• MDR Report Key: 25000136
• Report Number: 3004939290-2026-00482
• Device Sequence Number: 8750452
• Product Code: MGB
• UDI-Device Identifier: 10705032090278
• UDI-Public: (01)10705032090278(17)280224(10)F2605504
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): Unknown
• 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): 05/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: MX61260
• Device Lot Number: F2605504
• Was Device Available for Evaluation?: No
• 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: 04/01/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 04/27/2026
• Supplement Report FDA Received Date: 05/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2026
• 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: BSC FARPULSE.; CARTO MAPPING.; ICE CATHETER.
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White