FDA Adverse Event
Injury
Summary report: N
XCELA
MDR report key: 18474789
·
Received January 9, 2024
Report
- Report Number
- 18474789
- Event Type
- Injury
- Date Received
- January 9, 2024
- Date of Event
- December 11, 2023
- Report Date
- December 21, 2023
- Manufacturer
- NAVILYST MEDICAL, INC.
- Product Code
- LJT
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- NC
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
MALE PATIENT HAD PORT PLACED VIA INTERVENTIONAL RADIOLOGY. HE PRESENTED TO HIS ONCOLOGY OFFICE THE NEXT DAY FOR AN INFUSION. UPON FLUSHING THE PORT IN PREP FOR HIS INFUSION, THE PATIENT COMPLAINED OF PAIN. DUE TO THIS, THE PORT WAS NOT USED. THE NEXT DAY, PATIENT (PT) UNDERWENT A VENOGRAM, WHICH SHOWED THE PORT CATHETER HAD DISLODGED AND MIGRATED TO THE RIGHT ATRIUM. THE PT REQUIRED TRANSFER TO ANOTHER CAMPUS AND CT SURGERY CONSULT. FOUR DAYS AFTER PORT PLACEMENT, HE UNDERWENT SUCCESSFUL LOOP SNARE RETRIEVAL OF THE CATHETER, AND A NEW PORT WAS PLACED FOR HIS ONCOLOGY TREATMENT. IT IS UNKNOWN IF THE PORT/CATHETER WAS FAULTY OR IF IT WASN¿T CONNECTED PROPERLY. THE PORT/CATHETER WAS NOT SAVED FOR INSPECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 462309 | XCELA | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR | LJT | NAVILYST MEDICAL, INC. | H965451190 | 153231 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30660 DA | Male | Required Intervention| O |