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	01/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was scheduled for a three-year right heart catheterization (rhc) with sensor recalibration on (b)(6) 2026.Prior to the procedure, the patients' data was reviewed indicating mean pulmonary artery pressure and pulmonary pressure divergence from the initial relationship at the time of implant.Rhc with recalibration was completed on (b)(6) 2026 requiring a pressure adjustment of only 0.5mmhg and sensor accuracy was confirmed.
Additional Manufacturer Narrative
The manufacturer's investigation is ongoing.Additional information will be submitted via follow-up report within 30 days of receipt.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b4, g3, g6, h2, h6 and h11.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.On 9jan2026, the patient underwent a scheduled 3-year sensor recalibration via right heart catheterization which confirmed that the system was performing as intended and within the expected accuracy limits.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.Corrected data: d4: primary unique device identification.

• 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: 24209175
• Report Number: 3024985933-2026-00001
• Device Sequence Number: 14817296
• 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: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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: 11/07/2023
• Device Model Number: 100303
• Device Lot Number: E221031-01
• 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: 01/09/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2022
• 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: 81 YR
• Patient Sex: Female
• Patient Weight: 88 KG