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

Catalog Number	MX6721
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the plug of a 6/7f mynxgrip vascular closure device (vcd) was pulled out of the body when the device was removed after lsd, resulting in closure failure.The sealant was deployed to the proper location and subsequently dislodged.The vessel depth was not shallow.The sealant was deployed outside the vessel wall at the femoral artery puncture site; it was not completely above the skin and was partially in the tissue.The guidewire inside the balloon was found to be loop-shaped with a large outer diameter, as shown in the attachment.Hemostasis was achieved by manual compression for 15 minutes.There was no reported patient injury.The operator was highly experienced.The referenced guidewire was the soft guidewire that is part of the mynxgrip device and connects the atraumatic tip to the delivery shaft; it was a component of the mynxgrip device itself and was located between the atraumatic tip and the plug-release delivery shaft.No damage was found on the device or device packaging prior to opening.The advancer tube was held in place while the balloon was removed from the access site.A retrograde approach was used.The deployer was mynx certified.An 11f non-cordis short sheath was used.The femoral artery's suitability, including the vascular sheath introducer insertion angle of 30¿45 degrees, was verified.The vessel was arterial, and its diameter was verified to be at least 5 mm.There was no vessel tortuosity.The puncture location was the femoral artery, with no pvd or calcium in the vicinity of the puncture site.The device will be returned for evaluation.
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.

• 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: 50818008
• Report Number: 3004939290-2026-01301
• Device Sequence Number: 18811506
• Product Code: MGB
• UDI-Device Identifier: 10862028000410
• UDI-Public: (01)10862028000410(17)280317(10)F2607603
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: MX6721
• Device Lot Number: F2607603
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/03/2026
• 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: 08/21/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2026
• 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
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 127 LB