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	05/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be submitted via follow-up report within 30 days of receipt.
Event or Problem Description
Sensor inaccuracy suspected.Patient will undergo unscheduled recalibration to determine if an adjustment is needed.
Additional Manufacturer Narrative
Updated section(s) b5, g1, g6 and h2.(b5) additional information indicates that the patient will undergo right heart catheterization (rhc)/recalibration on (b)(6) 2025, to determine if an adjustment is needed.Additional information will be submitted via follow-up report within 30 days of receipt.
Additional Manufacturer Narrative
The following sections were updated: b4, b5, g3, g6, h2, h6 and h1.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Event or Problem Description
Additional information received indicated that the patient underwent a scheduled 3-year recalibration.A right heart catheterization (rhc) was performed to confirm the accuracy of the pressure sensor against a reference pressure.
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 remained implanted in the patient.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 (b)(6) 2025, 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.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.

• 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: 22141125
• Report Number: 3024985933-2025-00016
• Device Sequence Number: 12581883
• Product Code: MOM
• UDI-Device Identifier: 00850008997006
• UDI-Public: 850008997006
• 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: 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,Followup,Followup
• Report Date (Section B): 11/18/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/22/2023
• Device Catalogue Number: 100303
• Device Lot Number: E220308-01
• 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: 05/05/2025
• Supplement Date Received by Manufacturer: 06/27/2025; 08/27/2025; 10/31/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 07/16/2025; 09/22/2025; 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2022
• 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: Required Intervention
• Patient Sex: Female