FDA Adverse Event
Summary report: N
SMART PORT CT WITH VORTEX PORT
MDR report key: 1883743
·
Received October 11, 2010
Report
- Report Number
- 1883743
- Date Received
- October 11, 2010
- Date of Event
- September 23, 2010
- Report Date
- October 11, 2010
- Manufacturer
- ANGIODYNAMICS
- Product Code
- LJT
- Report Source
- User Facility report
- Reporter Location
- AR, US
Narratives
Description of Event or Problem · 1
PATIENT HAD PORT CATHETER PLACED IN LEFT SUBCLAVIAN AND RETURNED SEVEN MONTHS LATER WITH SUSPICION OF ACCESS LINE FRACTURE OF THE CATHETER. THE CATHETER WAS EVALUATED AND DURING THIS PROCESS RUPTURED INTO THE PROXIMAL PORTION. THE FRACTURED PORT CATHETER WAS SUCCESSFULLY REMOVED. THERE WAS NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SMART PORT CT WITH VORTEX PORT | CATHETER, IMPLANTED, PORT | LJT | ANGIODYNAMICS | CT96STSD | 519430 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | NO OTHER THERAPIES |