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	Hemoptysis (1887)
Date of Event	06/30/2025
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
Shortly after device implantation, the patient experienced coughing and hemoptysis, along with mild shortness of breath.These symptoms were addressed during hospitalization, and the patient has since recovered and been discharged.No further complications have been reported.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b4, g3, g6, h1, h2.H3, h4, h6 and h11.(h3) right heart catheterization is a procedure that carries inherent risks, including bleeding and vascular complications.Among these, hemoptysis is a known procedural complication and is noted in the product's risk documents and instructions for use as a potential risk of the overall procedure.Hemoptysis is typically a transient and reversable adverse event, which may occur secondary to patient factors and/or injury to the arterial vessel wall through handling of interventional products used during the implant procedure (such as guidewires or the delivery system).Despite these considerations, the cordella system provides meaningful clinical benefits through remote pulmonary artery pressure monitoring, which supports more effective management of chronic heart failure.The product used in this case was not returned for analysis and as such, a product malfunction could not be confirmed.Considering all information available at this time, handling and procedural factors (multiple guidewires used and difficulty gaining wire access at the target location due to patient anatomy) and/or patient factors (hypertension, vessel anatomy, large right ventricle, anti-platelet therapy) may have been contributing factors to this event.There is no evidence to suggest a design or manufacturing cause for this event.As such, no additional preventative or corrective actions are required.
Event or Problem Description
Additional information received indicates that during the implant procedure, vessel access was initially achieved but wire access was lost during advancement of the ds, requiring multiple rewiring attempts until successful deployment was completed using a 0.014 grand slam wire.The act was elevated at 305, above the recommended 200 prior to insertion.Post-procedure, the patient experienced minor coughing and shortness of breath, with a small amount of bleeding observed via suction.A chest x-ray was performed, oxygen therapy initiated, and protamine administered per physician orders before transfer to the icu for observation.Within 45-60 minutes, the patient stabilized with normal vital signs, was alert and oriented, and required no further intervention.The patient was discharged later that day, and by (b)(6) 2025, a clinical specialist confirmed he was home and recovering well.

• 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: 22581708
• Report Number: 3024985933-2025-00023
• Device Sequence Number: 15450112
• Product Code: MOM
• UDI-Device Identifier: 00850008997006
• UDI-Public: 850008997006
• Combination Product (Y/N): Y
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

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 Catalogue Number: 100303
• Device Lot Number: E240916-03
• 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: 06/30/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2024
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown