FDA Adverse Event
Other
Summary report: N
STARBURST XLI ENHANCED SEM-FLEX, 25CM, FLEXIB
MDR report key: 1661000
·
Received April 15, 2010
Report
- Report Number
- 1056436-2010-00028
- Event Type
- Other
- Date Received
- April 15, 2010
- Date of Event
- April 8, 2010
- Report Date
- April 15, 2010
- Manufacturer
- ANGIODYNAMICS
- Product Code
- GEI
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PT HAD DONUT SHAPED BURN ENCIRCLING THE ACCESS POINT. THE PT HAD A LIVER RFA PROCEDURE AND AN INTRODUCER SHEATH WAS USED (PART# 700-102636 LOT #C716). WE STARTED THE BURN 4CM DEPLOYMENT AS PER RECENT PROTOCOL CHANGES FOR THE LIVER LESION TREATMENTS TO TREAT A 7CM AREA. THE SKIN BURN EXTENDED CIRCUMFERENTIALLY FOR 3MM AROUND THE ACCESS SITES. NO TRACK ABLATION WAS USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STARBURST XLI ENHANCED SEM-FLEX, 25CM, FLEXIB | RFA PROBE | GEI | ANGIODYNAMICS | NA | 986695 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |