MAUDE Adverse Event Report: Cordis US Corp MYNX CONTROL; Device, Hemostasis, Vascular

Catalog Number	MX6760
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the sealant of a 6f¿7f mynx control vascular closure device (vcd) prematurely swelled during introduction into the sheath and became stuck, preventing advancement through the sheath.The device was removed due to inability to advance, and hemostasis was achieved by manual compression for less than 30 minutes.There was no reported patient injury.The device was stored and prepared according to the instructions for use, and the user was trained to the device.The device was inspected upon removal from the package, and no damage to the device or packaging was noted.A 6f non-cordis catheter sheath introducer was used.The sheath was flushed prior to device insertion, and the device was purged of air prior to use, with no delay between preparation and insertion.The sealant was not exposed prior to insertion.Resistance was encountered during insertion into the sheath.No evidence of intravascular sealant was observed.The device was returned for analysis.
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 has been analyzed but the final, approved draft of the engineering report and its conclusion 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: MYNX CONTROL
• 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: 50690797
• Report Number: 3004939290-2026-01255
• Device Sequence Number: 9684977
• Product Code: MGB
• UDI-Device Identifier: 10862028000434
• UDI-Public: (01)10862028000434(17)280115(10)F2601502
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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,Followup
• Report Date (Section B): 09/11/2026

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: MX6760
• Device Lot Number: F2601502
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/24/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/09/2026
• Supplement Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2026
• 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: Terumo Pinnacle 6F sheath introducer
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 149 LB