CORDELLA¿ PULMONARY ARTERY SENSOR SYSTEM
Report
- Report Number
- 3024985933-2025-00038
- Event Type
- Injury
- Date Received
- October 10, 2025
- Date of Event
- September 16, 2025
- Report Date
- January 29, 2026
- Manufacturer
- ENDOTRONIX, INC
- Product Code
- MOM
- PMA / PMN Number
- P230040
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE MANUFACTURER'S INVESTIGATION IS ONGOING. ADDITIONAL INFORMATION W9LL BE SUBMITTED VIA FOLLOW-UP REPORT WITHIN 30 DAYS OF RECEIPT.
THE FOLLOWING SECTIONS WERE UPDATED/ADDED: B4, G3, G6, H2. H3, H6 AND H11 (H3) 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 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 (1115 DAYS FROM IMPLANT), THE PATIENT UNDERWENT A SCHEDULED 3-YEAR 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. FOLLOWING RECALIBRATION, THE MPAP TREND HAS REMAINED STABLE AND CONSISTENT. WHILE THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED, THE MEASUREMENT STABILITY AFTERWARDS INDICATES THAT THE SENSOR'S INACCURATE MEASUREMENT WAS FINITE AND HAS BEEN EFFECTIVELY CORRECTED THROUGH RECALIBRATION. THE PRODUCT'S INSTRUCTIONS FOR USE WERE REVIEWED AND WARNS THE USER THAT, "TO ENSURE ACCURACY, THE SENSOR MUST BE CALIBRATED APPROXIMATELY EVERY THREE YEARS USING A RIGHT HEART CATHETERIZATION PROCEDURE." BASED ON THE INFORMATION PROVIDED, NO FURTHER CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.
THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4, G3, G6, H2 AND H11. (H3) 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 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 (1115 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. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. A POSSIBLE CAUSE COULD BE ATTRIBUTED TO A SUB-OPTIMAL RECALIBRATION PERFORMED ON (B)(6) 2023 FOR SUSPECTED DRIFT. THE PRESSURE ADJUSTMENT APPLIED DUE TO THIS RECALIBRATION COULD HAVE OVER-CORRECTED FOR THE DRIFT BEHAVIOR OF THE IMPLANT. BASED ON THE AVAILABLE INFORMATION, THE INVESTIGATION HAS NOT IDENTIFIED A SYSTEMIC ISSUE OR ADVERSE TREND. AS SUCH, ADDITIONAL CORRECTIVE AND PREVENTATIVE ACTIONS ARE NOT REQUIRED AT THIS TIME.
THE PATIENT UNDERWENT REGULARLY SCHEDULED 3-YEAR RECALIBRATION. 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 RECALIBRATION ADJUSTMENT WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2746118 | CORDELLA¿ PULMONARY ARTERY SENSOR SYSTEM | PULMONARY ARTERY SENSOR | MOM | ENDOTRONIX, INC | E220428-02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |