MAUDE Adverse Event Report: CORDIS US CORP. MYNXGRIP; DEVICE, HEMOSTASIS, VASCULAR

Catalog Number	MX5021
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the tamper tube and sealant of a 5f mynxgrip vascular closure device (vcd) did not deploy.The physician pulled the sheath back to the handle and everything came with it.The balloon was deflated and manual pressure was held for 25 minutes to achieve hemostasis.There was no reported patient injury.The user shuttled down completely with no significant resistance.No unusual force was applied when retracting the sheath.The advancer tube was not engaged or visible.No damage was identified on the device or packaging prior to opening.The device was stored and prepared according to the instructions for use (ifu).The device was used in an interventional procedure with a retrograde approach.The deployer had prior experience using the mynx device at other facilities.A 5fr non-cordis sheath introducer was used.An angiogram of the puncture site was performed.The device was used in an arterial vessel with a vessel diameter greater than or equal to 5 mm.The stick location was the lower one-third of the femoral head.The device will be returned for evaluation.

• Brand Name: MYNXGRIP
• Common Device Name: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; 5452 betsy ross drive; santa clara, california 95054 ; 7863138372
• MDR Report Key: 25237351
• Report Number: 3004939290-2026-00609
• Device Sequence Number: 10623574
• Product Code: MGB
• UDI-Device Identifier: 10862028000403
• UDI-Public: (01)10862028000403(17)280314(10)F2607304
• 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): 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): 06/23/2026

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: F2607304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2026
• 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: 04/24/2026
• Supplement Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 05/20/2026
• Supplement Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2026
• 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: UNKNOWN SHEATH.
• Patient Sex: Unknown