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	Hematoma (1884)
Date of Event	06/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported in the move study, a patient experienced groin swelling after the use of three 6-12f mynx control venous vascular closure device (vcd) in the right groin.An ultrasound was completed on follow up visit showing a 3.1 x 1.3 x 0.7 complex debris filled collection which is likely hematoma.Medication was provided as treatment.The device was used after an atrial fibrillation (afib) ablation using a non-cordis device.Venous access was gained with the use of ultrasound.One 7f, one 8f and one 10f sheath were use with approximately 6mm in between sites.Hemostasis was maintained after 5 minutes.The devices were successfully deployed.The patient received 23000 units of intraprocedural heparin and 50mg of protamine was administered.The activated clotting time (act) was 383 seconds.Procedural time was 33 minutes, and time to ambulation was 2.28 hours.The device was stored and prepped according to the ifu.The deployer was trained in the use of the device.The devices will not 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 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 ; +1(786)313-8372
• MDR Report Key: 50021217
• Report Number: 3004939290-2026-00984
• Device Sequence Number: 9572592
• Product Code: MGB
• UDI-Device Identifier: 10705032090278
• UDI-Public: (01)10705032090278(17280306(10)F2606504
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,Followup
• Report Date (Section B): 08/26/2026

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: F2606504
• 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: 06/29/2026
• Supplement Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2026
• 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: unknown sheath 7F/10F/9F.
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 208 LB