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

Catalog Number	100303-04
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Event or Problem Description
On (b)(6) 2025, the clinic contacted the manufacturer inquiring about potential drift/inaccuracy of the mycordella sensor that had been implanted in the patient.An assessment at the time of the initial report noted no evidence of drift and the clinical site was informed.On (b)(6) 2025 during proactive monitoring by the manufacturer, potential sensor drift/inaccuracy was noted.The clinical site was informed, and right heart catheterization (rhc) was recommended to recalibrate the mycordella sensor.As of 15-aug-2025, the rhc had not been completed.Additional attempts to gather information are ongoing.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: a1, a2, a3, a4, b4, g3, g6, h2.H3, h6, & h11.H2: all pressure transducers, regardless of the underlying technology or operating principle, have inherent baseline drift over time.The cordella sensor is a long-term implant designed to have low, characterized drift.The sensor is calibrated to a "gold standard" reference fluid-filled measurement on the day of implantation.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 remained implanted in the patient.The device history record (dhr) for the sensor lot was reviewed and it was confirmed that all manufacturing operations and inspections were performed, all acceptance criteria were met, and no relevant nonconformances were associated with the sensor lot at the time of manufacture.On (b)(6) 2025, the patient underwent a sensor recalibration via right heart catheterization which confirmed that the sensor offset fell outside the fluid-filled reference measurement error range, thereby confirming sensor drift.While a definitive root cause could not be determined, possible causes can be attributed, but not limited to, physical damage to the sensor, sensor response to the patient's physiology or body's internal environment, or an in vivo drift/settling profile that is different from the drift characterization and correction derived from manufacturing data.Since recalibration, the patient has returned to obtaining routine readings and no further corrective or preventative actions are required at this time.

• Brand Name: CARDELLA¿ 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
• MDR Report Key: 22888455
• Report Number: 3024985933-2025-00026
• Device Sequence Number: 20062465
• Product Code: MOM
• UDI-Device Identifier: 00850008997006
• UDI-Public: 850008997006
• Combination Product (Y/N): N
• 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: 2020
• 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): 11/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/22/2020
• Device Catalogue Number: 100303-04
• Device Lot Number: E200615-07
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/20/2020
• 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
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 66 KG