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	02/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On 03feb2026, the medical affairs team received an email from the site reporting that the patient had been admitted to the hospital with heart failure secondary to atrial fibrillation (unrelated to the cordella device).The patients cardiologist stated that the cordella sensor might require recalibration, as the reported values did not appear to correlate with the patients clinical presentation.At that time, there were no previous cases indicating sensor drift or suspected drift, and the patient had not undergone any reader exchanges or recalibrations.Review of the cordella data access platform (cdap) and bulk analysis showed electromagnetic interference (emi) less than 5 and signal strength above 3600.The physician requested a right heart catheterization and recalibration while the patient was admitted.On (b)(6) 2026, the patient underwent recalibration, and the results were within the fluid filled limits of agreement (ffloa).On (b)(6) 2026, endotronix r&d provided the ffloa determination.Post calibration flags were negative, with one negative supine reading attributed to high noise and emi.Subsequent readings were not negative, and there were no issues identified with calibration.A pressure adjustment increase was applied, and final results were within ffloa.
Additional Manufacturer Narrative
Additional information will be submitted via follow-up report within 30 days of receipt.
Additional Manufacturer Narrative
The following sections were updated/added: b4, g3, g6, h2.H3, h6 and h11.(h3) the sensor was not returned for evaluation as it remains implanted.The device history record (dhr) for the sensor lot was reviewed, and it was confirmed that no relevant nonconformances were associated with the sensor lot at the time of manufacture.On (b)(6) 2026 (450 days from implant), the patient underwent a right heart catheterization (rhc) recalibration.The offset determined during the recalibration fell inside the fluid-filled reference measurement error range, thereby confirming that the sensor was performing as expected.As a result, the reported event was not confirmed.Based on the information provided, no further corrective or preventative actions are required at this time.

• 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: kate jacobson ; 1415 w diehl rd #500w; naperville, IL 60563 ; 3316840727
• MDR Report Key: 24649802
• Report Number: 3024985933-2026-00007
• Device Sequence Number: 21292471
• Product Code: MOM
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P230040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

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: Health Professional
• Device Expiration Date: 01/23/2025
• Device Model Number: 100303
• Device Lot Number: E230110-07
• Was Device Available for Evaluation?: No
• 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: 02/18/2026
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2023
• 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 Sex: Male
• Patient Weight: 100 KG