FDA Adverse Event
Malfunction
Summary report: N
SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
MDR report key: 809547
·
Received October 27, 2006
Report
- Report Number
- 2954936-2006-00074
- Event Type
- Malfunction
- Date Received
- October 27, 2006
- Date of Event
- October 10, 2006
- Report Date
- October 25, 2006
- Manufacturer
- FOX HOLLOW TECHNOLOGIES, INC
- Product Code
- MCW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO: INVESTIGATION OF THE RETURNED DEVICE NOTED THAT THE TIP WAS DETACHED AT THE CUTTER WINDOW. THE TIP IS ALSO CRUSHED AT TWO PLACES, MEASURING 32MM AND 60MM FROM THE PROXIMAL END OF THE TIP. EACH CRUSHED AREA MEASURES APPROX 4MM IN LENGTH. THERE IS ALSO DAMAGE TO ONE SIDE OF THE CUTTER EDGE. IT APPEARS THAT THERE WAS AN INTERFERENCE FIT BETWEEN THE 7F SHEATH THAT WAS USED AND THE SILVERHAWK DEVICE. THE DAMAGE IS CONSISTENT WITH THE DEVICE BEING STUCK INSIDE THE SHEATH, REQUIRING EXCESSIVE FORCE AND OR TORQUE TO REMOVE IT.
Description of Event or Problem · 1
REPORTED AS: NOSECONE SEPARATION, THE NOSECONE WAS RETRIEVED VIA A FILTER WIRE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM | PERIPHERAL ATHERECTOMY CATHETER | MCW | FOX HOLLOW TECHNOLOGIES, INC | P4015 | 06051511 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |