MAUDE Adverse Event Report: CORDIS CORPORATION MYNXGRIP; DEVICE, HEMOSTASIS, VASCULAR

Catalog Number	MX5021
Medical Device Problem Codes	Retraction Problem (1536); Failure to Advance (2524); Difficult to Advance (2920)
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
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.
Event or Problem Description
As reported, when trying to deploy a 5f mynxgrip vascular closure device (vcd) the unknown sheath would not come back and it was removed as one unit undeployed.There is no report of injury to the patient.The patient recovered.The device was stored in the interventional radiology department.The mynx vcd was stored and prepared according to the instructions for use (ifu).Resistance/friction was experienced as the mynx vascular closure device (vcd) was advanced through the sheath.Significant resistance was experienced when shuttling down.Excessive force was not applied when shuttling down.Unusual force was applied when retracting the sheath; the physician was uncomfortable with the amount of force, deflated the balloon, and removed the device as one unit.The line was flushed with heparinized saline during the procedure and removed at the end.The procedure used a retrograde approach.The user was trained to mynx.A 5f non-cordis sheath was used.Femoral artery suitability was verified on angiography, including the insertion angle of the vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5 mm.The patient was not hospitalized, and the patient¿s hospitalization was not extended as a result of the event.The device will not be returned for evaluation.

• Brand Name: MYNXGRIP
• Common Device Name: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS US. CORP; 14021 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 5452 betsy ross drive; santa clara, CA 95054 ; 7863138372
• MDR Report Key: 25281683
• Report Number: 3004939290-2026-00631
• Device Sequence Number: 10095019
• Product Code: MGB
• UDI-Device Identifier: 10862028000403
• UDI-Public: (01)10862028000403(17)270507(10)F2512604
• 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): 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): 06/18/2026

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: F2512604
• Was Device Available for Evaluation?: No
• 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: 05/01/2026
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 05/26/2026
• Supplement Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2025
• 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 PINNACLE SHEATH BY TERUMO.
• Patient Sex: Unknown