CORDELLA¿ PULMONARY ARTERY SENSOR SYSTEM
Report
- Report Number
- 3024985933-2024-00009
- Event Type
- Malfunction
- Date Received
- September 10, 2024
- Date of Event
- August 20, 2024
- Report Date
- May 15, 2025
- Manufacturer
- ENDOTRONIX, INC
- Product Code
- MOM
- UDI-DI
- 00850008997006
- PMA / PMN Number
- P230040
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION WILL BE SUBMITTED VIA FOLLOW-UP REPORT WITHIN 30 DAYS OF RECEIPT.
CORRECTED DATA: SECTION G3: INITIAL REPORT DATE RECEIVED BY MANUFACTURER.
(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. THE PATIENT UNDERWENT A RIGHT HEART CATHETERIZATION (RHC) RECALIBRATION THREE YEARS AFTER IMPLANT WHICH CONFIRMED THAT THE SENSOR ACCURACY FALLS WITHIN THE ACCEPTABLE BETWEEN THE CORDELLA SYSTEM AND FLUID-FILLED REFERENCE MEASUREMENT. AS A RESULT, THE REPORTED INACCURATE MEASUREMENT ALLEGATION WAS NOT CONFIRMED.
SENSOR INACCURACY WAS SUSPECTED. PATIENT UNDERWENT REGULARLY SCHEDULED RECALIBRATION TO DETERMINE IF AN ADJUSTMENT WAS NEEDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 221702 | CORDELLA¿ PULMONARY ARTERY SENSOR SYSTEM | PULMONARY ARTERY SENSOR | MOM | ENDOTRONIX, INC | 00850008997006 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |