FDA Adverse Event
Malfunction
Summary report: N
FILTERWIRE EX SYSTEM
MDR report key: 363350
·
Received November 21, 2001
Report
- Report Number
- 2954755-2001-00007
- Event Type
- Malfunction
- Date Received
- November 21, 2001
- Date of Event
- September 7, 2001
- Report Date
- November 21, 2001
- Manufacturer
- BOSTON SCIENTIFIC/EPI
- Product Code
- MUN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DURING REMOVAL OF FILTERWIRE GUIDEWIRE FROM CAROTID ARTERY, PHYSICIAN FELT RESISTANCE AND FILTER LOOP/BAG BECAME DETACHED FROM GUIDEWIRE. ALL EFFORTS TO REMOVE THE FILTER LOOP/BAG COMPONENT FROM THE ARTERY FAILED. THE FILTER LOOP/BAG COMPONENT MIGRATED TO THE MIDDLE CEREBRAL ARTERY AND REMAINS THERE. PT WAS NOT TAKEN TO SURGERY. REMAINDER OF DEVICE WAS NOT RETURNED FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 53107 | FILTERWIRE EX SYSTEM | EMBOLIC PROTECTION GUIDEWIRE | MUN | BOSTON SCIENTIFIC/EPI | 19503 | 0103901 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Other |