MAUDE Adverse Event Report: CORDIS US CORP MYNX CONTROL; DEVICE, HEMOSTASIS, VASCULAR

Catalog Number	MX5060
Medical Device Problem Codes	Premature Activation (1484); Decrease in Pressure (1490); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the balloon of a 5f mynx control vascular closure device (vcd) would not inflate during device preparation.There was no reported patient injury.The device was stored and prepped according to the ifu.The balloon was prepped with 100% saline.While prepping for a case the cordis mynx was opened to be placed on the sterile field when it was noted to be broken where the balloon should deploy.The device never reached a patient.The device is being returned for evaluation.Addendum: a longitudinal tear on the balloon and a partially expose of the sealant were found on product 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.

• 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 ; 7863138372
• MDR Report Key: 25429060
• Report Number: 3004939290-2026-00687
• Device Sequence Number: 21410093
• Product Code: MGB
• UDI-Device Identifier: 20862028000424
• UDI-Public: (01)20862028000424(17)270812(10)F2522001
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 06/17/2026

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: MX5060
• Device Lot Number: F2522001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2026
• 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: 05/12/2026
• Supplement Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 06/08/2026
• Supplement Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2025
• 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: UNKNOWN.
• Patient Age: 61 YR
• Patient Sex: Male