MAUDE Adverse Event Report: CARDINAL HEALTH SANTA CLARA MYNX CONTROL; DEVICE, HEMOSTASIS, VASCULAR

Catalog Number	MX5060
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint conclusion: as reported, the sealant of a 5f mynx control vascular closure device (vcd) was not completely deployed during a closure attempt.The sealant or at least part of it was found at the distal tip of the delivery system.There was no reported patient injury.The device was not returned for analysis.A product history record (phr) review of lot f2600803 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported event of ¿mynx control system-deployment difficulty-partial¿ could not be observed as the device was not returned for analysis.The exact cause of the issue experienced could not be determined.Based on the limited information available for review, it is not possible to determine what factors may have contributed to the issue experienced.However, procedural/handling factors and/or concomitant device factors are possible.According to the instructions for use (ifu), which is not intended as a mitigation, step 2: deploy sealant, ¿while maintaining tension press button #1 until it is fully aligned with the handle, and the clock symbol is visible in the tension indicator window.This deploys and compresses the sealant against the arteriotomy.Lay the device down for 2 minutes.¿ the ifu also states in step 3: remove device, ¿retract the syringe plunger to lock position.Apply light fingertip compression proximal to the insertion site and then lightly grasp the device at skin with thumb and forefinger and realign with the tissue tract.Open the stopcock to deflate the balloon.To ensure complete balloon deflation, wait until air bubbles and fluid have stopped moving through the inflation tubing.Pick up the device handle and realign with the tissue tract.Depress button #2 to pull the deflated balloon into the device.While maintaining fingertip compression on the skin, remove the device from the patient.Continue to apply fingertip compression for up to 1 minute or as needed.Apply a sterile dressing once hemostasis is achieved.¿ neither the phr review, nor the information available for review suggests that the reported failure could be related to the design or manufacturing process of the unit.Therefore, no corrective/preventative actions will be taken at this time.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the sealant of a 5f mynx control vascular closure device (vcd) was not completely deployed during a closure attempt.The sealant or at least part of it was found at the distal tip of the delivery system.There was no reported patient injury.The device will be returned for evaluation.

• Brand Name: MYNX CONTROL
• Common Device Name: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): CARDINAL HEALTH SANTA CLARA; 5452 betsy ross drive; santa clara, california 95054
• 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
• MDR Report Key: 24602651
• Report Number: 3004939290-2026-00293
• Device Sequence Number: 8569069
• Product Code: MGB
• UDI-Device Identifier: 20862028000424
• UDI-Public: (01)20862028000424(17)280108(10)F2600803
• 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): 04/17/2026

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: F2600803
• 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: 02/16/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2026
• 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.
• Patient Sex: Unknown