FDA Adverse Event
Other
Summary report: N
CORDIS SUPER SOFT LU-SEE
MDR report key: 14844
·
Received April 29, 1994
Report
- Report Number
- 14844
- Event Type
- Other
- Date Received
- April 29, 1994
- Date of Event
- March 28, 1994
- Report Date
- April 21, 1994
- Manufacturer
- CORDIS CORP.
- Product Code
- DQX
- Report Source
- User Facility report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CORONARY WIRE FRACTURED OFF AT THE DISTAL END AND REMAINS IN THE DISTAL LAD ARTERY. THIS OCCURRED DURING REMOVAL OF THE BALLOON AND WIRE FROM THE CATHETER. THE RETAINED WIRE MEASURES 2 CM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CORDIS SUPER SOFT LU-SEE | GUIDE WIRE | DQX | CORDIS CORP. | 41193582 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Other |