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	07/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported in the move study, a patient experienced groin swelling and a 1.4cm hematoma after the use of four 6-12f mynx control venous vascular closure devices (vcd).Medication was provided for treatment.The devices were used after an svt ablation using a non-cordis device.Venous access was obtained in both groins with the use of ultrasound.An 8f and10f sheath were used in the left groin and a 6f and 8f sheath were used on the right groin.Approximately 7mm of distance was between access sites.Hemostasis was maintained after 5 minutes.The devices were successfully deployed.The patient received intraprocedural 11000 heparin and 50mg of protamine was administered.The activated clotting time (act) was 276 seconds.Procedural time was 86 minutes, and time to ambulation was approximately two 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: 50497740
• Report Number: 3004939290-2026-01187
• Device Sequence Number: 10211396
• Product Code: MGB
• UDI-Device Identifier: 10705032090278
• UDI-Public: (01)10705032090278(17)280416(10)F2610604
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/29/2026

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: F2610604
• 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: 08/03/2026
• Supplement Date Received by Manufacturer: 09/25/2026
• Initial Report FDA Received Date: 08/28/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2026
• 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 6F sheath
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 119 LB
• Patient Race: White