FDA Adverse Event
Malfunction
Summary report: N
FILTERWIRE EZ EMBOLIC SYSTEM (3.5MM - 5.5MM)
MDR report key: 1190806
·
Received September 24, 2008
Report
- Report Number
- 2134265-2008-02774
- Event Type
- Malfunction
- Date Received
- September 24, 2008
- Date of Event
- August 25, 2008
- Report Date
- August 25, 2008
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- NFA
- PMA / PMN Number
- K032884
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTIONAL (PCI) PROCEDURE, FILTER CLOSURE DIFFICULTIES WERE ENCOUNTERED. THE LOCATION OF THE LESION, PERCENT OF THE STENOSIS, DEGREE OF CALCIFICATION, AND VESSEL TORTUOSITY ARE UNKNOWN. THE FILTERWIRE EX EMBOLIC SYSTEM WAS PLACED. FOLLOWING THE INTERVENTION, THE PHYSICIAN WAS UNABLE TO PROPERLY CLOSE THE FILTER PRIOR TO REMOVAL, HOWEVER, THE FILTER WAS ABLE TO BE REMOVED "WITHOUT PATIENT COMPLICATION" TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT'S STATUS IS REPORTED AS "STABLE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FILTERWIRE EZ EMBOLIC SYSTEM (3.5MM - 5.5MM) | NFA DEVICE,CORONARY SAPHENOUS VEIN BYPASS GRAFT,TEMPORARY,FOR EMBOLIZATION PROTE | NFA | BOSTON SCIENTIFIC | 20100-399 | 0000820306 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |