FDA Adverse Event
Summary report: N
SILVERHAWIK LS-M
MDR report key: 2160569
·
Received July 8, 2011
Report
- Report Number
- 2160569
- Date Received
- July 8, 2011
- Date of Event
- June 22, 2011
- Report Date
- July 8, 2011
- Manufacturer
- EV-3 INC
- Product Code
- MCW
- Report Source
- User Facility report
- Reporter Location
- NY, US
Narratives
Description of Event or Problem · 1
WHILE PERFORMING A UNILATERAL EXTREMITY ANGIOPLASTY AND REMOVING THE SILVERHAWK, IT WAS DISCOVERED THAT THE WIRE HAD BECOME KINKED AND KNOTTED. THE DOCTOR ATTEMPTED TO STRAIGHTEN THE WIRE BEFORE PULLING OUT THE SILVERHAWK, SHEATH AND WIRE ALL TOGETHER. PRESSURE WAS HELD AND PUNCTURED CIRCUMFLEX LATERALIS ARTERY(LCF) TO CONTINUE PROCEDURE. WHILE USING A 7 X 200 BALLOON, THE BALLOON BURST. THE PTA CATHETER WAS REMOVED AND A SNARE WAS UTILIZED TO RETRIEVE THE FOREIGN BODY THAT WAS LEFT IN THE PATIENT. THE FOREIGN BODY WAS A LARGE PIECE OF THE BALLOON AND IT WAS FULLY RECOVERED.======================MANUFACTURER RESPONSE FOR ATHERECTOMY DEVICE, SILVERHAWIK LS-M (PER SITE REPORTER)======================NONE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SILVERHAWIK LS-M | ATHERECTOMY DEVICE | MCW | EV-3 INC | * | 9415859 | |
| 2 | EVERCROSS PTA BALLOON | EVERCROSS PTA BALLOON | LIT | EV-3 INC | * | 9441792 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR |