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	01/28/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer's investigation is ongoing.Additional information will be submitted via follow-up report within 30 days of receipt.
Event or Problem Description
During (b)(6) 2025 proactive monitoring by endotronix, suspected sensor drift was identified and the site was notified to pause use of pa readings as a parameter for determining patient treatment.On (b)(6) 2025, it was recommended that the patient undergo 3-year scheduled recalibration.On (b)(6) 2026, patient recalibration was completed successfully followed by monitoring and assessment of the patient data.On (b)(6) 2026, endotronix confirmed the sensor drift initially suspected in (b)(6) 2025 and concluded that there were no concerns with the calibration.
Additional Manufacturer Narrative
The following sections were updated, corrected: b4, d4, g3, g6, h2, h3, h6 and h11.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 (1666 days from implant), the patient underwent a right heart catheterization (rhc) recalibration.The offset determined during the recalibration fell outside the fluid-filled reference measurement error range, thereby confirming that the sensor was providing inaccurate measurements.The products instructions for use that was effective at the time of the reported event warned the user that, to ensure accuracy, the sensor must be calibrated approximately every three years using a right heart catheterization procedure.Additionally, the instruction for use stated that post-implant, the sensor may need to be recalibrated if there is anomalous pa pressure data.Based on the information provided, no further corrective or preventative actions are required at this time.Corrected data: section d4: lot number.

• 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: 24474368
• Report Number: 3024985933-2026-00003
• Device Sequence Number: 10230557
• Product Code: MOM
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P230040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2026

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 Expiration Date: 09/15/2021
• Device Model Number: 100303
• Device Lot Number: E200902-02
• 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: 01/28/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2020
• 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: 79 YR
• Patient Sex: Male
• Patient Weight: 110 KG