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

Catalog Number	100303-05
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemothorax (1896)
Date of Event	10/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer's investigation is ongoing.Additional information will be submitted via follow-up report within 30 days of receipt.
Event or Problem Description
Post-implant of a cordella sensor on (b)(6) 2025, the patient experienced a sudden drop in blood pressure as manual compression was held at the access site (jugular access).A ct scan was performed to rule out complications such as stroke or retroperitoneal bleeding (rp), and the patient was admitted to the intensive care unit (icu) for monitoring.By (b)(6) 2025, reports indicated that the patient had returned to baseline with no signs of stroke or retroperitoneal bleed.The physician later confirmed the patient had bled into the pleural space due to a challenging neck access but was stable and breathing room air.The patient exited the intensive care unit by (b)(6) 2025 and was discharged home by (b)(6) 2025 when post-implant training with the cordella system was successfully completed.
Additional Manufacturer Narrative
The following sections were updated/added: b4, g3, g6, h2, h3, h6 and h11.(h3) the sensor (b)(6) was not returned for evaluation since it remains implanted within the patient.A review of the manufacturing records for delivery system w/ sensor (b)(6) did not reveal any issues or nonconformances that could be related to the reported event.Right heart catheterization is a procedure that carries inherent risks, including bleeding and vascular complications.Among these, hemothorax is a recognized and potentially serious adverse event, which may occur secondary to vascular injury during procedural manipulation with interventional products (such as guidewires or the delivery system).In this case, handling and procedural factors (difficulty gaining neck access, multiple guidewires used) may have contributed to the event.Hemothorax is a recognized procedural complication and is addressed in the product's risk documentation and instructions for use.Despite these risks, the cordella pa sensor system provides meaningful clinical benefits by enabling remote pulmonary artery pressure monitoring, supporting improved management of chronic heart failure.The delivery system used in this case was not returned for analysis.Procedural film or imaging was not available for review.Considering all information available at this time, known right heart catheterization risks or handling and procedural factors (prolonged case time due to failed rij access) may have been a contributing factor to this event.There is no evidence to suggest a design or manufacturing issue caused or contributed to this event.

• 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: 23658010
• Report Number: 3024985933-2025-00040
• Device Sequence Number: 15966379
• Product Code: MOM
• UDI-Device Identifier: 00850008997006
• UDI-Public: 850008997006
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/12/2026
• Device Catalogue Number: 100303-05
• Device Lot Number: E240102-03
• 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: 10/29/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2024
• 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: Other; Required Intervention
• Patient Sex: Male