FDA Adverse Event
Injury
Summary report: N
TURBOHAWK¿ PLAQUE EXCISION SYSTEM
MDR report key: 2040495
·
Received April 6, 2011
Report
- Report Number
- 2183870-2011-00057
- Event Type
- Injury
- Date Received
- April 6, 2011
- Date of Event
- March 8, 2011
- Report Date
- March 8, 2011
- Manufacturer
- EV3 INC.
- Product Code
- MCW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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
A CHRONIC TOTAL OCCLUSION (CTO) OF THE LEFT POPLITEAL WAS CROSSED WITH 0.035 WIRE AND 0.035 CATHETER. IT WAS THEN PRE-DILATED WITH 3.0X40 PTA BALLOON. THE PHYSICIAN THEN PERFORMED ATHERECTOMY WITH THE TURBOHAWK THS-SX-C. POST ANGIOS SHOWED EMBOLI IN THE POSTERIOR TIBIAL (PT). THE PT WAS WIRED WITH A .014 WIRE AND THE PHYSICIAN EXTRACTED THE THROMBUS WITH AN EXPORT CATHETER. ONCE COMPLETE, FLOW WAS RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TURBOHAWK¿ PLAQUE EXCISION SYSTEM | CATHETER, PERIPHERAL, ATHERECTOMY | MCW | EV3 INC. | THS-SX-C | 9408673 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | .035 TRAILBLAZER SUPPORT CATHETER| 7F EXPORT CATHETER| .035 GLIDEWIRE |