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

Catalog Number	MX5060
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
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, button #1 of three 5f mynx control vascular closure devices jammed and could not be pushed down at all or all the way down, and the sealant was never deployed extravascular to the tissue tract.There was no reported patient injury.The balloon worked and created temporary hemostasis, and the tension indicator aligned with the markers on the handle halves before attempting to deploy.There was not any kinks in the sheath or device after removal.The sealant sleeves were noted to be part open after removal.A new mynx device from a different box was used to close the groin.It was reported that three failures occurred out of one box with the same lot number.The device storage temperature did not exceed 25 °c.The device was stored and prepped according to instructions for use (ifu).The user is trained to the device and the device was used in the femoral artery.The device will not be returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, button #1 of a 5f mynx control vascular closure devices jammed and could not be pushed down at all or all the way down, and the sealant was never deployed extravascular to the tissue tract.There was no reported patient injury.The balloon worked and created temporary hemostasis, and the tension indicator aligned with the markers on the handle halves before attempting to deploy.There weren¿t any kinks in the sheath or device after removal.The sealant sleeves were noted to be part open after removal.A new mynx device from a different box was used to close the groin.It was reported that three failures occurred out of one box with the same lot number.The device storage temperature did not exceed 25 °c.The device was stored and prepped according to instructions for use (ifu).The user is trained to the device, and the device was used in the femoral artery.The device was not returned for evaluation.The product history record (phr) review of lot f2601504 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported event of ¿button #1-frozen/locked¿ 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 information available for review, it is not possible to determine what factors may have contributed to frozen/locked button 1 experienced.However, procedural/handling factors (even though it was reported that the tension indicator was aligned prior to attempting button 1 depression) are possible.Although not intended as a mitigation of risk, the information for safety within the instructions for use (ifu) is provided in the product¿s labeling with the intent to make the user aware of the risks.According to the mynx control ifu, ¿grasp the device handle and align the device with the tissue tract.Pull gently to retract the device until the black line in the tension indicator window aligns with the markers on the side, indicating the balloon is abutting the arteriotomy with the correct amount of tension.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.¿ neither the phr review, nor the information available for review suggests that the reported issue could be related to the design or manufacturing process of the unit.Therefore, no corrective/preventative actions will be taken at this time.

• 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, florida 33014
• Manufacturer Contact: karla castro ; 5452 betsy ross drive; santa clara, california 95054 ; 7863138372
• MDR Report Key: 24786559
• Report Number: 3004939290-2026-00377
• Device Sequence Number: 10037182
• Product Code: MGB
• UDI-Device Identifier: 20862028000424
• UDI-Public: (01)20862028000424(17)280115(10)F2601504
• 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): 04/21/2026

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: F2601504
• 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: 03/09/2026
• Supplement Date Received by Manufacturer: 04/12/2026
• Initial Report FDA Received Date: 04/04/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2026
• 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