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	08/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the plug of a 6/7f mynxgrip vascular closure device (vcd) could not be released.There was no reported patient injury.The procedure was interventional and used a retrograde approach.The deployer was mynx certified.The sheath introducer information was unknown; the sheath size was 6f.The vascular sheath introducer insertion angle was 30-45 degrees.The vessel was the femoral artery and was greater than 5 mm in diameter.There was no vessel tortuosity and no peripheral vascular disease (pvd)/calcium in the vicinity of the puncture site.Hemostasis was achieved with manual compression for 20 minutes.The user shuttled down completely with no significant resistance, and no unusual force was applied when retracting the sheath.The advancer tube was not visible.The device is being returned for evaluation.
Additional Manufacturer Narrative
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.This device is available for analysis, but the engineering report is not yet available.However, it 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 ; 5452 betsy ross drive; santa clara, CA 95054 ; +1(786)313-8372
• MDR Report Key: 50786355
• Report Number: 3004939290-2026-01288
• Device Sequence Number: 18534361
• Product Code: MGB
• UDI-Device Identifier: 10862028000410
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P040044
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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: MX6721
• Device Lot Number: F2610405
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/03/2026
• 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: 08/20/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2026
• 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 Cordis sheath.
• Patient Sex: Unknown