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

Catalog Number	100303
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	05/21/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Additional information will be submitted via follow-up report within 30 days of receipt.
Event or Problem Description
The patient was successfully implanted with cordella pulmonary artery sensor.The patient was stable following the procedure.Several hours later, the patient coded and expired in icu.
Additional Manufacturer Narrative
The following sections were updated/added: b4, g3, g6, h2, h3, h6 and h11.(h3) the device was not received for analysis, nor was an autopsy provided.Review of all available clinical information precludes determination of a definitive cause of death.The patient's complex medical history, including advanced heart failure, severe copd, obesity, diabetes, ckd, and substance abuse, may have increased procedural risk contributing to the adverse outcome.Additionally, a review of all available procedural information received from edwards ihfm clinical specialists and the site (internal case reports, meeting minutes, and the site debrief meeting) noted procedural challenges that were evident, particularly during wire placement and advancement and removal of the first delivery system.Review of all manufacturer's device history records (dhr) confirms that the device met all design and manufacturing specifications.The product labeling warns that only trained personnel should use the cordella pulmonary artery sensor system and notes potential risks associated with the overall procedure, including but not limited to, hemoptysis and vascular/bleeding complications.While the root cause of the reported event cannot be conclusively determined, there is no evidence to suggest that a device malfunction or deficiency contributed to the adverse outcome.There are clinical and procedural factors that may have 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: 22290115
• Report Number: 3024985933-2025-00015
• Device Sequence Number: 8467894
• Product Code: MOM
• UDI-Device Identifier: 00850008997006
• UDI-Public: 850008997006
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/12/2026
• Device Catalogue Number: 100303
• 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: 05/21/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 10/28/2025
• 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: Life Threatening; Death; Required Intervention
• Patient Sex: Unknown