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

Catalog Number	100303
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Updated section(s) d4, g3, g6, h2, h3, h4 and h6: (h3) the sensor remains implanted and was not returned for evaluation.A review of the device history record (dhr) for the associated lot confirmed that all manufacturing operations and inspections were completed per specifications, acceptance criteria were met, and no relevant nonconformances were identified at the time of manufacture.Approximately 11150 days post-implantation of the mycordella sensor, the patient underwent a scheduled 3-year right heart catheterization (rhc) recalibration.During this procedure, the offset measured fell outside the acceptable fluid-filled reference error range, indicating that the sensor was providing inaccurate pulmonary artery pressure readings.The observed drift, although rare, may be attributed to factors such as physical damage or an in vivo drift/settling profile that deviates from the correction parameters derived during manufacturing.Recalibration was successfully performed, confirming the drift was finite, the sensor was undamaged, and the corrective action restored the system to its intended accuracy.Based on available data, the most probable cause of the drift was an in vivo settling profile inconsistent with manufacturing-derived expectations.No further complications were reported following recalibration, and the system continues to operate within specified performance parameters.
Additional Manufacturer Narrative
Additional information will be submitted via follow-up report within 30 days of receipt.
Event or Problem Description
The patient was reviewed by endotronix's internal monitoring where it was determined that this patient is suspected for sensor inaccuracy.The clinical specialist (cs) emailed the site coordinator letting them know to stop treating based on mpap and to schedule a recalibration.Patient will undergo regularly scheduled 3-year recalibration on (b)(6) 2025 to determine if an adjustment is needed.
Additional Manufacturer Narrative
Updatedsection(s) b1, b2, b5, b6, g3, g6.H1, h2 and h6.(b5) additional information received indicates that a right heart catheterization (rhc) was performed to confirm the accuracy of the pressure sensor against a reference pressure.The sensor was found to be outside the range of accuracy; therefore, a calibration during rhc via swan-ganz confirmed that a sensor adjustment of 14.0mmhg was required.Additional information will be submitted via follow-up report within 30 days of receipt.

• 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: 21919158
• Report Number: 3024985933-2025-00011
• Device Sequence Number: 9073534
• Product Code: MOM
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P230040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/20/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/24/2022
• Device Catalogue Number: 100303
• Device Lot Number: E210811
• 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: 04/03/2025
• Supplement Date Received by Manufacturer: 06/26/2025; 07/22/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 07/09/2025; 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2021
• 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: Required Intervention
• Patient Sex: Male