XCELA
Report
- Report Number
- 1317056-2025-00090
- Event Type
- Injury
- Date Received
- April 1, 2025
- Date of Event
- December 29, 2016
- Report Date
- April 8, 2025
- Manufacturer
- PFM MEDICAL, INC.
- Product Code
- LJT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 003
Narratives
ADDITIONAL INFORMATION: FURTHER INFORMATION WAS OBTAINED WHICH ESTABLISHED THAT THE DEVICE IN QUESTION IS AN XCELA POWER INJECTABLE PORT. (B)(4) IS A DISTRIBUTOR OF THIS DEVICE AND DOES NOT HOLD REPORTING RESPONSIBILITY. A FORMAL NOTIFICATION OF THIS EVENT HAS BEEN SENT TO THE MANUFACTURER, PFM MEDICAL, INC.
THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AN INVESTIGATION INTO THE ROOT CAUSE FOR THE EVENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. REFERENCE (B)94).
ON OR ABOUT (B)(6)2016, PLAINTIFF UNDERWENT PLACEMENT OF THE ANGIODYNAMICS XCELA PORT. THE DEVICE WAS IMPLANTED BY DR. BROCK CARNEY, M.D., AT FREEMAN HEALTH SYSTEM IN JOPLIN, MISSOURI FOR THE PURPOSE OF ADMINISTRATION OF CHEMOTHERAPY. ON OR ABOUT (B)(6) 2016, PLAINTIFF WAS SEEN AT FREEMAN HEALTH SYSTEM, IN JOPLIN, MISSOURI FOR REMOVAL OF THE XCELA PORT DUE TO BLOODSTREAM INFECTION AND INFLAMMATORY REACTION DUE TO CENTRAL VENOUS CATHETER. ON OR ABOUT (B)(6) 2017, THE DEFECTIVE DEVICE WAS REMOVED BY DR. (B)(6) JEYARAJ, MD AT FREEMAN HEALTH SYSTEM IN JOPLIN, MISSOURI.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 832397 | XCELA | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR | LJT | PFM MEDICAL, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention| L| O| H |