FDA Adverse Event
Other
Summary report: N
J-TIP STEERABLE GUIDEWIRE/MEDTRONIC AVE LIGHT SUPPORT
MDR report key: 679821
·
Received January 25, 2006
Report
- Report Number
- 679821
- Event Type
- Other
- Date Received
- January 25, 2006
- Date of Event
- December 31, 2005
- Report Date
- January 25, 2006
- Manufacturer
- MEDTRONIC VASCULAR
- Product Code
- DQX
- Report Source
- User Facility report
- Reporter Location
- PA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DURING EMERGENT CARDIAC CATHETERIZATION AND PTCA (PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY), THE TIP OF THE FLOPPY GUIDEWIRE BROKE OFF INTO THE DIAGONAL CORONARY ARTERY. THERE WAS NO PATIENT INJURY ASSESSED ON FOLLOW-UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | J-TIP STEERABLE GUIDEWIRE/MEDTRONIC AVE LIGHT SUPPORT | GUIDEWIRE CATHETER | DQX | MEDTRONIC VASCULAR | LSPTLJ300 | 0000129686 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |