MAUDE Adverse Event Report: Endotronix, Inc Cordella Pulmonary Artery Sensor System

Model Number	100303
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2026
Type of Reportable Event	Serious Injury

• Brand Name: Cordella Pulmonary Artery Sensor System
• Common Device Name: Pulmonary Artery Sensor
• Manufacturer (Section D): Endotronix, Inc; 1415 w diehl rd; #500w; naperville IL 60563
• Manufacturer (Section G): Endotronix, Inc; 1415 w diehl rd; #500w; naperville IL 60563
• Manufacturer Contact: karina majors ; 1415 w diehl rd; #500w; naperville, IL 60563
• MDR Report Key: 50786350
• Report Number: 3024985933-2026-00037
• Device Sequence Number: 15845528
• Product Code: MOM
• UDI-Device Identifier: 00850008997006
• UDI-Public: (01)00850008997006(11)241111
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P230040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 100303
• Device Catalogue Number: 100303-05
• Device Lot Number: E240916-03
• Was Device Available for Evaluation?: No
• 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: 08/18/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Weight: 168 LB