MAUDE Adverse Event Report: Cordis US. Corp MYNXGRIP; Device, Hemostasis, Vascular

Catalog Number	MX6721
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a 6f/7f mynxgrip vascular closure devices (vcd) failed to deploy the plug properly.Manual compression was held for 15 minutes and there were no reported injuries to the patient.The user shuttled down completely, there was no significant resistance during shuttle down, no unusual force was applied when retracting the sheath, there were no kinks in the sheath or device after removal, and the device storage temperature did not exceed 25 °c.A non-cordis sheath 5f × 10 was used.The device was used in the common femoral artery (cfa).Femoral artery suitability, including the vascular sheath introducer insertion angle, was verified on angiography or venography.The vessel type was arterial, the vessel diameter was verified to be at least 5 mm, there was little to no vessel tortuosity, and there was no peripheral vascular disease (pvd) or calcium near the puncture site.The device was stored and prepared according to the instructions for use (ifu).The mynx vascular closure device (vcd) was used during an interventional peripheral procedure using a retrograde approach.The deployer was mynx certified.The devices will not be returned for evaluation.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: MYNXGRIP
• 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 ; 14021 nw 60 avenue; miami lakes, FL 33014 ; +1(786)313-8372
• MDR Report Key: 50914920
• Report Number: 3004939290-2026-01344
• Device Sequence Number: 5330440
• Product Code: MGB
• UDI-Device Identifier: 10862028000410
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: MX6721
• Device Lot Number: 18608702
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/13/2026
• 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: Terumo Pinnacle 5x10
• Patient Sex: Male
• Patient Weight: 162 LB