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

Catalog Number	MX6760
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	04/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the polyethylene glycol (peg) material of a 6-12f mynx control venous vascular closure device (vcd) was associated with backing out at the access site.There was a reported patient injury of inflammation and cellulitis requiring antibiotic treatment.The site where the device was used appeared inflamed and cellulitic, and antibiotics were administered with no further treatment required.The patient recovered after the mynx event.The device will not be returned for evaluation because the incident happened at an office follow-up.Sterile technique was followed.The patient did not receive prophylactic antibiotics prior to the procedure.The patient was under anesthesia during the procedure, and the procedure was performed as outpatient.The access site was cleaned and maintained post-procedure with chloraprep.The patient was not immunocompromised and had not experienced a recent infection.No damages were found on the device or device packaging prior to opening.The device was stored and prepped in accordance with the instructions for use (ifu).The deployer was mynx certified.A cordis sheath introducer was used.The device will not be returned for evaluation.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: MYNX CONTROL
• 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: 25303168
• Report Number: 3004939290-2026-00639
• Device Sequence Number: 9307534
• Product Code: MGB
• UDI-Device Identifier: 10705032090278
• UDI-Public: (01)10705032090278(17)280306(10)F2606504
• 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): 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): 06/25/2026

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: MX6760
• Device Lot Number: F2606504
• 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: 04/29/2026
• Supplement Date Received by Manufacturer: 06/24/2026
• Initial Report FDA Received Date: 05/27/2026
• Supplement Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown