FDA Adverse Event
Injury
Summary report: N
LIFEPORT VTX VASCULAR ACCESS SYSTEM
MDR report key: 1212223
·
Received October 20, 2008
Report
- Report Number
- 1056436-2007-00017
- Event Type
- Injury
- Date Received
- October 20, 2008
- Date of Event
- February 15, 2007
- Report Date
- October 20, 2008
- Manufacturer
- ANGIODYNAMICS, INC.
- Product Code
- LJT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINT, "X-RAY REVEALED THE CATHETER WAS SPLIT UNDERNEATH THE COLLAR BONE", WAS CONFIRMED. THE ATTACHED POLYURETHANE CATHETER SEGMENT REVEALED DAMAGES CONSISTENT WITH LUMINAL NARROWING, COMPRESSION AND LONGITUDINAL SLITS. THESE DAMAGES APPEAR CONSISTENT WITH CATHETER FRACTURE BY "PINCH-OFF SYNDROME".
Description of Event or Problem · 1
A LIFEPORT VASCULAR ACCESS PORT CAGALOG # LVTX-7513 FROM LOT # 28233 WAS IMPLANTED IN 2006. CHEST X-RAY AFTER PROCEDURE SHOWED SATISFACTORY POSITIONING AND NO PNEUMOTHORAX. THE PT WAS UNDERGOING CHEMOTHERAPY FOR LYMPHOMA. WHEN INABILITY TO ACCESS THE PORT WAS REPORTED, AN X-RAY WAS DONE AND REVEALED THE CATHETER WAS SPLIT UNDERNEATH THE COLLAR BONE. THE PORT WAS REMOVED IN 2007, AND REPLACED WITH A PORT FROM LOT# 29207.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPORT VTX VASCULAR ACCESS SYSTEM | VASCULAR ACCESS PORT | LJT | ANGIODYNAMICS, INC. | NA | 28233 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |