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	04/25/2025
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
The patient was reviewed by endotronix's internal monitoring where it was determined that this patient is suspected of sensor inaccuracy.The patient will undergo recalibration on (b)(6) 2025, to determine if an adjustment is needed.
Additional Manufacturer Narrative
Updated section(s) b5, g3 and g6.(b5) additional information received indicates that patient recalibration was postponed and a new date to be determined by the site.
Additional Manufacturer Narrative
Updated section(s) b5, g3 and g6.(b5) additional information received indicates that the patient will undergo 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.
Event or Problem Description
Additional information received indicated that the patient underwent an unscheduled right heart catheterization (rhc)/recalibration.A right heart catheterization (rhc) was performed to confirm the accuracy of the pressure sensor against a reference pressure.
Additional Manufacturer Narrative
Updated section(s) b1, b2, b5, b6, g3, g6, h1, h2, h3, h6 and h11.(h3) 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 2025-08-12, the patient underwent an unscheduled 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.Following recalibration, the mpap trend has remained stable and consistent.While the exact cause of the reported event cannot be conclusively determined, the measurement stability afterwards indicates that the sensor's inaccurate measurement was finite and has been effectively corrected through recalibration.The product's instructions for use was reviewed and warns the user that, "to ensure accuracy, the sensor must be calibrated approximately every three years using a right heart catheterization (rhc) procedure.".

• 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: 22030428
• Report Number: 3024985933-2025-00013
• Device Sequence Number: 12827118
• Product Code: MOM
• UDI-Device Identifier: 00850008997006
• UDI-Public: 850008997006
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/05/2025

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: 01/23/2024
• Device Catalogue Number: 100303
• Device Lot Number: E230110-07
• 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: 04/25/2025
• Supplement Date Received by Manufacturer: 05/30/2025; 06/25/2025; 08/12/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 06/25/2025; 07/16/2025; 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2023
• 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: Male