FDA Adverse Event
Injury
Summary report: N
SYNTEL EMBOLECTOMY CATHETER 5F 80CM
MDR report key: 702047
·
Received April 20, 2006
Report
- Report Number
- 2027111-2006-00010
- Event Type
- Injury
- Date Received
- April 20, 2006
- Date of Event
- March 25, 2006
- Report Date
- April 20, 2006
- Manufacturer
- APPLIED MEDICAL RESOURCES CORP.
- Product Code
- DXE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
"SURGEON USING SYNTAL CATHETER IN LEFT LEG TIP OF CATHETER BROKE OFF INSIDE ARTERY THAT THEY WER BYPASSING." ORIGINAL CUSTOMER EXPERIENCE REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNTEL EMBOLECTOMY CATHETER 5F 80CM | EMBOLECTOMY CATHETER | DXE | APPLIED MEDICAL RESOURCES CORP. | A4F06 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Hospitalization |