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

Catalog Number	100303-05
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
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
Following successful implant of the sensor, the reader was not able to detect a signal lock on to and calibrate the sensor.After multiple attempts and troubleshooting, it was determined that the sensor had failed.Despite these issues, the patient remains clinically stable with no clinical consequences and continues to take daily vital sign (bp, pulse oximetry and weight) readings utilizing the cordella heart failure system (chfs).
Additional Manufacturer Narrative
H11: the following sections were updated/corrected/added: a2, a3, a4, b4, g3, g6, h2, h6, & h11.H2: evaluation summary: the sensor was not returned as it remains implanted.All images and in-process manufacturing inspections and test results were reviewed.This sensor passed all functional and visual checks, and there was no sign of any abnormalities in its weld line inspections, integrity inspection, or hermiticity results.Additionally, the sensor passed interrogation after sterilization.Therefore, all build/testing documentation supports and provides evidence that this sensor was conforming to all specifications and functioning as intended prior to distribution.Based on the available information, the reported event was confirmed; however, the root cause could not be conclusively determined.Sensor failure is a known event and is addressed in the products risk documents with potential contributing factors including, but not limited to, large link-distance between the reader and the sensor.The event appears to be isolated in nature and endotronix will continue to trend complaints of this nature.

• Brand Name: CARDELLA¿ 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
• MDR Report Key: 22792968
• Report Number: 3024985933-2025-00025
• Device Sequence Number: 20993431
• Product Code: MOM
• UDI-Device Identifier: 00850008997006
• UDI-Public: 850008997006
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P230040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2025

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
• Device Expiration Date: 01/12/2025
• Device Catalogue Number: 100303-05
• Device Lot Number: E240102-03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/24/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 138 KG