CORDELLA¿ PULMONARY ARTERY SENSOR SYSTEM
Report
- Report Number
- 3024985933-2024-00003
- Event Type
- Injury
- Date Received
- August 20, 2024
- Date of Event
- July 16, 2024
- Report Date
- June 13, 2025
- Manufacturer
- ENDOTRONIX, INC
- Product Code
- MOM
- UDI-DI
- 00850008997006
- PMA / PMN Number
- P230040
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, 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.
UPDATED SECTION(S) B1, B2, B4, B5, B6, D4, G3, G6, H1, H2, AND H6. SECTION 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. IT WAS NOTED THAT THE SENSOR CALIBRATION WAS OUTSIDE THE FLUID FILLED LIMITS OF AGREEMENT; THEREFORE, AN ADJUSTMENT WAS REQUIRED.
UPDATED SECTION(S): G6, H3 AND H6: H3: THE SENSOR REMAINS IMPLANTED AND WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD CONFIRMED ALL MANUFACTURING CRITERIA WERE MET WITH NO NONCONFORMANCES. SINCE (B)(6) 2023, A DIVERGENCE OF OVER 10 MMHG IN MPAP TRENDS WAS NOTED, INITIALLY ATTRIBUTED TO THE PATIENT'S WEIGHT. IN (B)(6) 2024, THE MONITORING PROGRAM FLAGGED THE SENSOR FOR POTENTIAL INACCURACY. THE SITE WAS INFORMED OF THE LIKELY INACCURACY AND ADVISED NOT TO USE THE PA PRESSURE MEASUREMENTS FOR TREATMENT DECISIONS. RECALIBRATION WAS NOT PERFORMED AS THE PATIENT WAS CLINICALLY STABLE. THEREFORE, THE SUSPECTED SENSOR DRIFT REMAINS UNCONFIRMED.
UPDATED SECTION(S) B4, B5, G3, G6, H1, H2, AND H6. SECTION B5: ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE SENSOR IS LOCATED IN THE RIGHT PULMONARY ARTERY (RPA), WITH DISTAL AND PROXIMAL ANCHORS SECURELY ATTACHED TO THE SENSOR BODY. THE DEPLOYMENT OCCURRED IN AN ANTERIOR BRANCH, RESULTING IN THE OBSERVED ROTATION. (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, THE PATIENT UNDERWENT A RIGHT HEART CATHETERIZATION (RHC) RECALIBRATION (PATIENT WAS IMPLANTED WITH THE SENSOR FOR 1125 DAYS BEFORE THE 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 SITE REPORTED SUSPECTED SENSOR INACCURACY. THE PATIENT WILL NEED RECALIBRATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2395964 | CORDELLA¿ PULMONARY ARTERY SENSOR SYSTEM | PULMONARY ARTERY SENSOR | MOM | ENDOTRONIX, INC | 00850008997006 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |