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

Catalog Number	MX6760
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	05/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to system limitations, section h6 required to input investigation findings, and investigation conclusions for an initial report.Pending additional information to complete investigation.A review of the manufacturing documentation associated with lot f2605002 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the sealant of a 6/7f mynx control vascular closure device (vcd) was removed along with the device.Manual compression was used to achieve hemostasis in less than 30 minutes.There wad no reported patient injury.The device was stored and prepped according to the ifu, the user was trained, and the device was inspected and prepped as stated in the ifu with no abnormalities detected.The device storage temperature was controlled in the storage room.The device was used for a diagnostic left heart catheterization.A non-cordis 6f sheath was used.The device was inserted into a sheath, the balloon was inflated and pulled back, button 1 was depressed, 2 minutes elapsed, the balloon was deflated, and button 2 was pressed.The sealant deployed under the skin, on top of the arteriotomy, upon depressing button 1.The sealant was dislodged from the arteriotomy upon removal of the device according to the instructions for use (ifu) protocol.The sealant did not stick to the device.Button 1 was fully depressed, the balloon was fully deflated, button 2 was fully depressed, and no additional resistance was noted.Access was reported as a good stick with a vessel large enough for mynx closure, and no abnormalities with calcium were noted.The device will not be returned for evaluation.

• Brand Name: MYNX CONTROL
• 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: 25501642
• Report Number: 3004939290-2026-00734
• Device Sequence Number: 21462743
• Product Code: MGB
• UDI-Device Identifier: 10862028000434
• UDI-Public: (01)10862028000434(17)280219(10)F2605002
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/24/2026

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: MX6760
• Device Lot Number: F2605002
• 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: 05/19/2026
• Supplement Date Received by Manufacturer: 06/24/2026
• Initial Report FDA Received Date: 06/15/2026
• Supplement Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2026
• 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: 6F TERUMO SHEATH.; CARDIAC CATHETERIZATION.
• Patient Sex: Unknown