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	Thrombosis/Thrombus (4440)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a vascular surgeon reported that the patient presented to the emergency room with groin pain following a prior electrophysiology procedure (ep) with closure using three 6f¿12f mynx control venous vascular closure devices (vcd).Ultrasound showed deep vein thrombosis (dvt).It was noted that this was the only information available, and the location of the original electrophysiology procedure was unknown.The device will not be returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, a vascular surgeon reported that the patient presented to the emergency room with groin pain following a prior electrophysiology procedure (ep) with closure using three 6f¿12f mynx control venous vascular closure devices (vcd).Ultrasound showed deep vein thrombosis (dvt).It was noted that this was the only information available, and the location of the original electrophysiology procedure was unknown.The devices were not returned for analysis.A product history record (phr) review of lot f2534004 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.A deep vein thrombosis (dvt) is a known potential complication and is listed in the mynx control venous vcd instructions for use (ifu) as such.A dvt occurs when a blood clot forms in a deep vein, most commonly in the lower leg [calf] and can spread up to the veins in the thigh.A dvt is the result of three principal factors: reduced or stagnant blood flow in the deep veins (venous stasis); injury to the blood vessel wall; or an increase in the activity of those substances in the blood that are part of the normal clotting mechanism, a condition called hypercoagulability (which means a more active clotting state).The act of creating a venotomy with a catheter sheath introducer produces intended damage to the vessel wall in order to obtain access to the patient¿s vasculature for diagnostic or interventional purposes.The intended injury to the vessel wall triggers the immune system to heal the damaged areas, thus activating the clotting mechanism as well as the inflammatory response.The combination of inflammatory response and clotting cascade can lead to thrombus formation inside of the punctured vessel.Usually, anticoagulants are prescribed in order to prevent the formation of thrombosis at the puncture sites.Vessel occlusions usually require additional intervention, such as thrombectomy, stenting, or surgical intervention in order to restore/improve flow.Without the return of the devices for analysis or procedural films, the reported event could not be observed, and no determination of possible product contributing factors could be made.Based on the information available for review, it is not possible to draw a clinical conclusion between the devices and event.However, patient and pharmacological factors are likely.Although not intended as a mitigation of risk, the information for safety within the ifu and patient brochure is provided in the product¿s labeling with the intent to make the user and patient aware of the risks.According to the mynx control venous ifu, ¿apply a sterile dressing once hemostasis is achieved.It is recommended that the patient follow physician orders regarding patient ambulation and discharge.Refer to patient brochure for post-care instructions.¿ according to the patient brochure, ¿please contact your doctor immediately if you experience any of the following: persistent pain, tenderness, tingling or swelling at the puncture site or leg.Bleeding, oozing or drainage at the puncture site.Increased redness, warmth, bruising or swelling at the puncture site.Non-healing wound.Any other unusual symptoms.¿ it also instructs, ¿modify activity for 3 days or more: no driving on day of discharge.No strenuous activity, exercise, pushing or pulling.No heavy lifting of anything over 5 pounds.Avoid driving unless necessary.Avoid stairs, but if necessary, go slowly.While coughing, sneezing, or straining for a bowel movement: press with your palm on top of the dressing/bandage.Consult your doctor about returning to work or sexual activity.¿ neither the phr review, nor the available information suggests that the reported event is related to the design or manufacturing process of the units.Therefore, no corrective or preventative actions will be taken at this time.

• 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, california 95054 ; 7863138372
• MDR Report Key: 25054072
• Report Number: 3004939290-2026-00503
• Device Sequence Number: 18687051
• Product Code: MGB
• UDI-Device Identifier: 10705032090278
• UDI-Public: (01)10705032090278(17)271206(10)F2534004
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 05/01/2026

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: F2534004
• 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: 04/10/2026
• Initial Report FDA Received Date: 05/01/2026
• Date Device Manufactured: 12/06/2025
• 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
• Patient Sex: Unknown
• Patient Weight: 73 KG