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

Catalog Number	MX5060
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the sealant sleeve of a 5f mynx control vascular closure device (vcd) split open prematurely exposing the sealant during insertion through a hemostatic valve of a non-cordis sheath.The device was removed, and another 5f mynx control vascular closure device (vcd) was used to successfully achieve hemostasis.There was no reported patient injury.The device was inserted through a sheath placed in the left common femoral artery following a pulsed field ablation (pfa) procedure, and resistance was felt during insertion when the issue was observed.The sealant sleeves (cartridge assembly) were not out of position and no damage was noted; however, there was exposure of the sealant to blood that contacted the sealant, likely due to damage to the sealant sleeves.The package was opened by a circulating nurse, and the sterile tray was removed by hand by the scrub technician.No damage was noted to the device or packaging prior to opening.The device was stored and prepared according to the instructions for use (ifu).The sheath was not kinked or bent upon removal.The user was trained on the device.A retrograde approach was used during an electrophysiology ablation procedure.No visible bend or damage was observed in the distal end of the balloon shaft after removal.No excess force was applied during insertion.The access site vessel was not tortuous.A non-cordis sheath was used.The femoral artery suitability and vessel diameter greater than or equal to 5 mm were verified, with no tortuosity, peripheral vascular disease, or calcium at the puncture site.The patient¿s body mass index was reported as greater than 40 kg/m².The device will be returned for evaluation.
Additional Manufacturer Narrative
This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.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, florida 33014
• Manufacturer Contact: karla castro ; 14021 nw 60 avenue; miami lakes, florida 33014 ; 7863138372
• MDR Report Key: 24994009
• Report Number: 3004939290-2026-00478
• Device Sequence Number: 9884852
• Product Code: MGB
• UDI-Device Identifier: 20862028000424
• UDI-Public: (01)20862028000424(17)271008(10)F2528102
• 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): 06/10/2026

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: MX5060
• Device Lot Number: F2528102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2026
• 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: 04/02/2026
• Supplement Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 04/26/2026
• Supplement Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 5F 10CM TERUMO PINNACLE SHEATH
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Race: White