FDA Adverse Event
Malfunction
Summary report: N
TURBOHAWK LXM
MDR report key: 4083798
·
Received August 29, 2014
Report
- Report Number
- 4083798
- Event Type
- Malfunction
- Date Received
- August 29, 2014
- Date of Event
- June 17, 2014
- Report Date
- August 29, 2014
- Manufacturer
- COVIDIEN INC.
- Product Code
- MCW
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- IN, US
Narratives
Description of Event or Problem · 1
THE TURBOHAWK ATHERECTOMY DEVICE WAS UTILIZED FOR SEVERAL PASSES THROUGH THE RIGHT SUPERFICIAL FEMORAL ARTERY, POPLITEAL ARTERY, AND TIBIAL/PERONEAL ARTERIES. WHEN THE DEVICE WAS REMOVED, IT WAS NOTED THE CUTTING PORTION WAS PULLED APART FROM THE CATHETER BUT WAS STILL ATTACHED. THE CATHETER WAS NOT REINSERTED INTO THE PATIENT'S BODY AS THE ATHERECTOMY PORTION OF THE PROCEDURE WAS FINISHED. NO PART WAS LEFT IN PATIENT'S BODY.======================MANUFACTURER RESPONSE FOR ATHERECTOMY DEVICE, TURBOHAWK LXM (PER SITE REPORTER).======================SALE REPRESENTATIVE TOOK PRODUCT WITH HER ON THE DAY OF THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 527630 | TURBOHAWK LXM | ATHERECTOMY DEVICE | MCW | COVIDIEN INC. | * | 9880572 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR |