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	02/11/2026
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 sensor accuracy and concluded that there were no concerns with the calibration.
Additional Manufacturer Narrative
The following sections were updated- added b4, g3, g6, h2, h3, h6 and h11.H3: suspected sensor inaccuracy or sensor drift is the gradual deviation in pressure readings over time.In cases where sensor inaccuracy is suspected, physicians can rely on alternative clinical indicators to guide continued patient care.The patient may elect to undergo sensor recalibration via right heart catheterization at a time determined collaboratively with the care team.In this case, 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 all manufacturing operations and inspections were performed, all acceptance criteria were met, and no relevant nonconformances were associated with the sensor lot at the time of manufacture.Record-data review for the sensor recalibration notes that the sensor was found to be functioning as intended.Following recalibration, the mpap trend remained stable and consistent.The offset determined during the recalibration fell within the fluid-filled reference measurement error range, thereby confirming that the sensor was providing accurate measurements.As a result, the reported event was not confirmed.With review of all available information, there is no indication of a design or manufacturing related cause for the event and no further corrective or preventative action is 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: 24500284
• Report Number: 3024985933-2026-00004
• Device Sequence Number: 10486361
• 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: 2023
• 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): 03/20/2026

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: 09/20/2023
• Device Model Number: 100303
• Device Lot Number: E220907-04
• 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: 02/11/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2022
• 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: 35 YR
• Patient Sex: Male
• Patient Weight: 98 KG