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

Catalog Number	MX61260
Medical Device Problem Code	Therapy Delivered to Incorrect Body Area (1508)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a 6f -12fmynx control venous vascular closure device (vcd) came out with the peg still attached.The peg did not fall out of the mynx vcd shaft upon removal and remained attached, although it was found outside the shaft.It was reported that button #2 was not depressed as the device was pulled out before that step.Hemostasis was achieved using a suture with stop cock.There were no reported injuries to the patient.The device was inserted into a 9f avanti plus catheter sheath introducer (csi) and the deployment directions were followed.This was during an atrial fibrillation (afib) ablation.The patients body mass index (bmi) was 44.The device was stored and prepared according to the instructions for use.The device storage temperature did not exceed 25 °c.The procedure was performed using an antegrade approach by a deployer who was certified on the mynx device.Femoral vein suitability was verified on venography, including confirmation of the appropriate 30¿45-degree insertion angle of the vascular sheath introducer, and vessel tortuosity was described as little.No resistance was noted during use of the device.The device will be returned for evaluation.

• 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, california 95054 ; 7863138372
• MDR Report Key: 25125948
• Report Number: 3004939290-2026-00532
• Device Sequence Number: 18815181
• Product Code: MGB
• UDI-Device Identifier: 10705032090278
• UDI-Public: (01)10705032090278(17)280306(10)F2606503
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2026

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
• Device Catalogue Number: MX61260
• Device Lot Number: F2606503
• 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: 04/14/2026
• Supplement Date Received by Manufacturer: 05/17/2026
• Initial Report FDA Received Date: 05/08/2026
• Supplement Report FDA Received Date: 05/29/2026
• 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: 9F AVANTI PLUS CSI
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 139 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White