FilterWire EZ?
Received Jul 29, 2026 · Event occurred Jul 3, 2026
Report 2124215-2026-40559 · MDR key 50068889
Device
Generic name
Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Manufacturer
Boston Scientific CorporationModel number
H749201001900Catalog number
H749201001900
Lot number
0036083409
Product problems
- Difficult to Remove
- Difficult to Advance
Patient
53 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that removal difficulty occurred.The target lesion was located in the carotid artery. A 190 cm FilterWire EZ? was selected for use. During the procedure, upon retraction of the FilterWire, the retrieval sheath failed to advance to the plain body section of the device due to significant resistance. The physician could only attempt to directly withdraw the opened retrieval sheath of the FilterWire together with the guiding catheter out of the body. The procedure was completed with another of the same device. There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1 - (b)(6).