FDA Adverse Event
Injury
Summary report: N
CORDELLA¿ PULMONARY ARTERY SENSOR SYSTEM
MDR report key: 22589222
·
Received July 24, 2025
Report
- Report Number
- 3024985933-2025-00024
- Event Type
- Injury
- Date Received
- July 24, 2025
- Date of Event
- July 14, 2025
- Report Date
- September 30, 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
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
UPDATED SECTIONS: A2, A3, A4, B4, G3, G6, H1, H2, H6 AND H11. H3: THE PATIENT UNDERWENT RECALIBRATION OF THE MYCORDELLA SENSOR DURING WHICH THE OFFSET MEASURED FELL WITHIN THE ACCEPTABLE ERROR RANGE; SENSOR ACCURACY WAS CONFIRMED.
Additional Manufacturer Narrative · 0
ADDITIONAL INFORMATION WILL BE SUBMITTED VIA FOLLOW-UP REPORT WITHIN 30 DAYS OF RECEIPT.
Description of Event or Problem · 0
THE SITE REPORTED SUSPECTED SENSOR INACCURACY. A SECOND RHC WAS PERFORMED ON (B)(6) 2025 TO CONFIRM THE ACCURACY OF THE PRESSURE SENSOR AGAINST A REFERENCE PRESSURE. IT WAS NOTED THAT THE SENSOR CALIBRATION WAS WITHIN THE FLUID FILLED LIMITS OF AGREEMENT; THEREFORE, NO ADJUSTMENT WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1921650 | CORDELLA¿ PULMONARY ARTERY SENSOR SYSTEM | PULMONARY ARTERY SENSOR | MOM | ENDOTRONIX, INC | E220713-08 | 00850008997006 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Female | Required Intervention |