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

Catalog Number	MX61260
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the sealant of a 6-12f mynx control venous vascular closure device (vcd) was not completely unsheathed from the device.Mild damage was noted to the sealant sleeves after removal.Manual compression was held for hemostasis.The device was used with an 8f sheath.The other two sites in the left groin were closed successfully.The device was discarded during case clean up.The procedure used a retrograde approach.The deployer was trained on the mynx device.An 8f avanti sheath introducer was used.The device was stored and prepared according to the instructions for use.No damage was noted to the button.The button completely depressed.The tension indicator was aligned with the markers on the handle halves before deployment.The device storage temperature exceeded 25 °c.No kinks were noted in the sheath or device after removal.The tension indicator displayed a clock symbol after button #1 depression.The device is not being returned for evaluation.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot f2609901 presented no issues during the manufacturing process that can be related to the reported event.Due to system limitations, section h6 required to input type of investigation, investigation findings, and investigation conclusions for an initial report.Pending additional information to complete investigation.

• 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, CA 95054 ; 7863138372
• MDR Report Key: 25430267
• Report Number: 3004939290-2026-00691
• Device Sequence Number: 10205109
• Product Code: MGB
• UDI-Device Identifier: 10705032090278
• UDI-Public: (01)10705032090278(17)280409(10)F2609901
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 06/19/2026

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: MX61260
• Device Lot Number: F2609901
• 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: 05/12/2026
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 06/08/2026
• Supplement Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2026
• 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: 8F AVANTI SHEATH.
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 63 KG