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

Catalog Number	100303
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	04/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be submitted via follow-up report within 30 days of receipt.
Event or Problem Description
The site reported suspected sensor inaccuracy.The patient had a sensor recalibration on (b)(6) 2025.A right heart catheterization (rhc) was performed to confirm the accuracy of the pressure sensor against a reference pressure.
Additional Manufacturer Narrative
Updated sections: g3, g6, h2 and h6.The 5.346 mmhg difference that sensor (b)(6) exhibited during the recalibration falls within the within the fluid-filled limits of agreement (ff loa) and confirmed system accuracy.(patient was implanted with the sensor for 834 days before the recalibration).This, combined with the evidence showing the sensor was manufactured per specifications, that the calibrations were found acceptable, and that the reader was found to be performing as intended confirms that the system was performing as intended and within expected accuracy limits.As a result, the reported inaccurate measurement allegation was not confirmed.

• 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: 22029711
• Report Number: 3024985933-2025-00012
• Device Sequence Number: 8151585
• Product Code: MOM
• UDI-Device Identifier: 00850008997006
• UDI-Public: 850008997006
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2025

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: Lay User/Patient
• Device Expiration Date: 11/07/2023
• Device Catalogue Number: 100303
• Device Lot Number: E221031-01
• 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: 04/23/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2022
• 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