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	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the tamper tube of a 5f mynxgrip vascular closure device (vcd) did not deploy when the shuttle and sheath were brought back up to meet the green handle.The mynxgrip vascular closure device (vcd) was removed, and manual pressure was held.There was no reported patient injury.Ultrasound was used for access, and the patient had no vessel abnormalities.The mynx vascular closure device (vcd) was used in an interventional procedure with a retrograde approach.The physician was reported to be well knowledgeable regarding the mynx device.A cordis avanti 5f sheath was used.Femoral artery suitability was verified with ultrasound.The vessel was arterial, the vessel diameter was verified to be greater than or equal to 5 mm, and there was no vessel tortuosity or peripheral vascular disease/calcium in the vicinity of the puncture site.Hemostasis was achieved with manual pressure for 20 minutes.The user shuttled down completely, with no significant resistance when shuttling down and no unusual force applied when retracting the sheath.The advancer tube was engaged or visible.The patient had a retroperitoneal hemorrhage following a urologic procedure.The physician performed coil embolization of the lower pole of the left renal artery branch.He stick site was at the femoral head.The device will be 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.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: 50947622
• Report Number: 3004939290-2026-01364
• Device Sequence Number: 10429188
• Product Code: MGB
• UDI-Device Identifier: 10862028000403
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 09/30/2026

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?: Yes
• Date Returned to Manufacturer: 09/17/2026
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/30/2026
• 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 Avanti sheath
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 182 LB