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

Catalog Number	MX5021
Medical Device Problem Codes	Failure to Fire (2610); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the white internal stylet of a 5f mynx grip vascular closure device (vcd) was not exposed on deployment.There was no reported patient injury.The device was not returned because the account threw it away.The procedure used a retrograde approach.The deployer was mynx certified.The sheath french size was 5f.Femoral artery suitability was verified on angiography or venography, including the vascular sheath introducer insertion angle of 30¿45 degrees.The vessel was arterial, and the vessel diameter was verified to be greater than or equal to 5 mm.The user shuttled down completely, however there was significant resistance when shuttling down.The advancer tube was not engaged or visible.The device is not 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.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 ; 5452 betsy ross drive; santa clara, CA 95054 ; +1(786)313-8372
• MDR Report Key: 50755473
• Report Number: 3004939290-2026-01278
• Device Sequence Number: 18451968
• Product Code: MGB
• UDI-Device Identifier: 10862028000403
• UDI-Public: (01)10862028000403(17)280507(10)18582225
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): N
• 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): 09/20/2026

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: MX5021
• Device Lot Number: 18582225
• 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: 08/19/2026
• Supplement Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 09/14/2026
• Supplement Report FDA Received Date: 09/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2026
• 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: 5F sheath
• Patient Sex: Unknown