FDA Adverse Event
Other
Summary report: N
SINGLE LUMEN EMBOLECTOMY CATHETER
MDR report key: 888424
·
Received August 2, 2007
Report
- Report Number
- 1220948-2007-00011
- Event Type
- Other
- Date Received
- August 2, 2007
- Date of Event
- March 29, 2007
- Report Date
- June 4, 2007
- Product Code
- DXE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PHYSICIAN USED THE LEMAITRE EMBOLECTOMY CATHETER FOR A VENOUS THROMBECTOMY CASE. THE LEMAITRE EMBOLECTOMY CATHETER IS CONTRAINDICATED FOR USE FOR VENOUS THROMBECTOMY. THE PHYSICIAN DID NOT FOLLOW THE IFU. A COPY OF THE IFU IS BEING SENT WITH THIS REPORT. ADD'L MODEL # 1601-58, ADD'L CATALOG# 1601-58.
Description of Event or Problem · 1
THE PHYSICIAN USED A LEMAITRE EMBOLECTOMY CATHETER FOR A VENOUS THROMBECTOMY CASE. FURTHER DETAILS ON PT INJURY, VESSEL DAMAGE, IS UNK AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SINGLE LUMEN EMBOLECTOMY CATHETER | EMBOLECTOMY CATHETER | DXE | 1601-48 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |