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	08/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the white internal stylet of a 6/7f mynx grip vascular closure device (vcd) was not exposed during deployment.There was no reported patient injury.The user shuttled down completely, and significant resistance was encountered while shuttling down.The advancer tube was not engaged or visible.No damage was found on the device or device packaging prior to opening.The device was stored and prepped in accordance with the instructions for use (ifu).A retrograde approach was used.The deployer was mynx certified.The femoral artery¿s 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 stick location was the common femoral artery (cfa).The device will 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 ; 5452 betsy ross drive; santa clara, CA 95054 ; +1(786)313-8372
• MDR Report Key: 50774405
• Report Number: 3004939290-2026-01284
• Device Sequence Number: 21444079
• Product Code: MGB
• UDI-Device Identifier: 10862028000410
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 09/15/2026

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: 18583719
• 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: 08/19/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2026
• 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: n/a
• Patient Sex: Unknown