FDA Adverse Event
Injury
Summary report: N
TURBOHAWK¿ PLAQUE EXCISION SYSTEM
MDR report key: 2132588
·
Received June 17, 2011
Report
- Report Number
- 2183870-2011-00122
- Event Type
- Injury
- Date Received
- June 17, 2011
- Date of Event
- May 5, 2011
- Report Date
- May 19, 2011
- Manufacturer
- EV3 INC.
- Product Code
- MCW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MANUFACTURING RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THIS REPORTED EVENT.
Description of Event or Problem · 1
THIS PROCEDURE IS PART OF THE (B)(4). A 1.7 CM ANEURYSM WAS DETECTED IN THE RSFA ( TARGET LESION ) ON A 30 DAY DUPLEX, FOLLOWING TURBOHAWK PROCEDURE WHICH OCCURED ON (B)(6), 2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TURBOHAWK¿ PLAQUE EXCISION SYSTEM | CATHETER, PERIPHERAL, ATHERECTOMY | MCW | EV3 INC. | THS-LS-C | 9396703 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Other |