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

Model Number	100303-05
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a sensor was deployed in the anterior position for a patient.Initial calibration attempts yielded a signal strength of 85%, though interference required mitigation.Subsequent attempts failed to reach the 80% threshold necessary for locking.After approximately 10 minutes, the physician performed fluoroscopy, revealing that the sensor had shifted distally and rotated toward the collarbone.Post-operatively, calibration attempts from the chest using an alloy reader were unsuccessful due to the patient's body size and breathing pattern, which caused fluctuating signal strength below 80%.Calibration was ultimately achieved from the patient's back, with seated readings reaching approximately 85%, though signal strength remained unstable.The patient was discharged with the alloy reader but was unable to perform readings without assistance.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: mfr number, a1, a2, a3, 84, d4, g6, h2, h4, h6, & h11.H2: correction: the initial medwatch report for this event was submitted on 2025-10-02 under mfr number (core id: ci251002152625.C625fd214b3149b 7 a esd 12e4627bac20), which was within the required timeframe.However, the report was submitted under an incorrect reference number.This follow-up report serves as the final report and includes all previously submitted information along with any additional updates.The correct reference number for this report is.H2: the cardella implant is designed for deployment within the right pulmonary artery distal to the apical branch.The implant body is positioned on the anterior wall of the right pulmonary artery with the distal anchor extending down the downturn of the vessel.The distal anchor design ensures resistance to proximal movement of the implant and ensures rotational self-alignment of the implant body with the target placement position of the reader on the patient's chest.The proximal anchor provides additional stability and apposition of the implant body against the vessel wall.The sensor was not returned for evaluation as it remained implanted in the patient.The device history record (ohr) 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.A review of the sensor images during and directly after deployment confirmed that the implant positioning and orientation were optimal.There were no noted abnormalities related to structural integrity of the sensor during or after deployment.However, imaging of the sensor conducted during calibration revealed that it had moved distal to the target zone and had rotated towards the collarbone.Therefore, the reported event was confirmed.While the exact cause of the reported event cannot be conclusively determined, it is noted that it is possible for the sensor to have slightly rotated superior upon deployment due to patient anatomy.The patient is currently able to take readings from the back using an alloy reader.Based on the information available for review, there is no indication of a design or manufacturing cause for the event; therefore, no additional 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
• MDR Report Key: 23693966
• Report Number: 3024985933-2025-00036
• Device Sequence Number: 10375798
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/02/2025

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: 01/12/2026
• Device Model Number: 100303-05
• Device Lot Number: E240102
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 12/02/2025
• Date Device Manufactured: 05/24/2024
• 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 Age: 68 YR
• Patient Sex: Male
• Patient Weight: 164 KG