MAUDE Adverse Event Report: ENDOTRONIX, INC CORDELLA¿ PULMONARY ARTERY SENSOR SYSTEM

Catalog Number	100303
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be submitted via follow-up report within 30 days of receipt.
Event or Problem Description
The site suspected sensor inaccuracy and the patient was reviewed by endotronix's internal monitoring where it was determined that this patient is suspected for sensor inaccuracy.The clinical specialist (cs) emailed the site coordinator letting them know to stop treating based on mpap.The patient will be scheduled for recalibration.
Additional Manufacturer Narrative
The following sections were updated/added: b4, g3, g6, h2, h3, h6 and h11.(h3) the suspected sensor inaccuracy could not be confirmed as the device remains implanted in the patient and rhc/recalibration has not been completed.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.Out of an abundance of caution, the treating physician has been informed of the potential inaccuracy of the sensor readings and instructed not to use the pulmonary artery (pa) measurements to guide treatment decisions.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.The product's instructions for use were reviewed and warns the user that, "to ensure accuracy, the sensor must be calibrated approximately every three years using a right heart catheterization procedure." based on the information provided, no further corrective or preventative actions are required at this time.Reference also 3024985933-2024-00012.

• 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: 22581705
• Report Number: 3024985933-2025-00022
• Device Sequence Number: 20829603
• Product Code: MOM
• UDI-Device Identifier: 00850008997006
• UDI-Public: 850008997006
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P230040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/15/2022
• Device Catalogue Number: 100303
• Device Lot Number: E211206-08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2022
• 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
• Patient Sex: Female