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

Model Number	100303
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is one of two manufacturer reports being submitted for the same event.Reference related manufacturer report number 3024985933 2025 00030.The investigation remains ongoing at this time.Additional information will be submitted in a follow up report within 30 days of receipt.
Event or Problem Description
On (b)(6) 2026 the patient underwent a right heart catheterization (rhc) recalibration procedure.The sensor offset was determined to be outside the acceptable fluid filled reference measurement error range, confirming that the sensor was providing inaccurate measurements.
Additional Manufacturer Narrative
The following sections were updated, corrected, or added; report number should be fei not cfn, g1, g3, g6, h2, h3, h6, & h11.This is a continuation of (b)(4)/medwatch 3024985933-2025-00030.H11.Suspected sensor inaccuracy or sensor drift is the gradual deviation in pressure readings over time.In cases where sensor inaccuracy is suspected, physicians can rely on alternative clinical indicators to guide continued patient care.The patient may elect to undergo sensor recalibration via right heart catheterization at a time determined collaboratively with the care team.In this case, the sensor was not returned for evaluation as it remains implanted.The device history record (dhr) for the sensor lot was reviewed, and it was confirmed that no relevant nonconformances were associated with the sensor lot at the time of manufacture.On (b)(6) 2026 (1085 days from implant), the patient underwent a right heart catheterization (rhc) recalibration.The offset determined during the recalibration fell outside the fluid filled reference measurement error range, thereby confirming that the sensor was providing inaccurate measurements.The products instructions for use were reviewed and note that endotronix monitors sensor performance over time.When analysis suggests anomalous sensor performance, recalibration using the rhc procedure may be required.If anomalous data is confirmed through the internal monitoring program, endotronix will notify the site.The instructions for use further state that when anomalous readings are suspected, corrective recalibration using the rhc procedure may be necessary.Based on the available information no further 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 road; 500w; naperville FL 60563
• Manufacturer (Section G): ENDOTRONIX, INC.; 1415 w diehl road; 500w; naperville FL 60563
• Manufacturer Contact: kate jacobson ; 1415 w diehl road; 500w; naperville, FL 60563 ; 6304733200
• MDR Report Key: 24649770
• Report Number: 3024985933-2026-00006
• Device Sequence Number: 18582107
• Product Code: MOM
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P230040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2026

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: Lay User/Patient
• Device Expiration Date: 01/12/2026
• Device Model Number: 100303
• Device Lot Number: E230110-07
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Female
• Patient Weight: 107 LB