FILTERWIRE EZ
Received Jul 2, 2026 · Event occurred Jun 3, 2026
Report 2124215-2026-35654 · MDR key 25699812
Device
Generic name
Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Manufacturer
Boston Scientific CorporationModel number
44150Catalog number
44150
Lot number
0037595408
Product problems
- Material Integrity Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
E1 - INITIAL REPORTER ADDRESS 1: (B)(6).
Description of Event or Problem
IT WAS REPORTED THAT THE RADIOPAQUE NITI LOOP OF THE FILTERWIRE WAS PARTIALLY DETACHED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED SAPHENOUS VEIN GRAFT. A 190 CM FILTERWIRE EZ WAS SELECTED FOR USE. DURING THE PROCEDURE, THE RADIOPAQUE NITI LOOP OF THE FILTERWIRE WAS PARTIALLY DETACHED AND SUBSEQUENTLY RETRIEVED BY THE RETRIEVAL SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT STATUS POST PROCEDURE WAS STABLE.