FILTERWIRE EZ?
Received Jul 7, 2026 · Event occurred Jun 11, 2026
Report 2124215-2026-36344 · MDR key 25738412
Device
Generic name
Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Manufacturer
Boston Scientific CorporationModel number
H749201001900Catalog number
H749201001900
Lot number
0035419796
Product problems
- Material Split, Cut or Torn
Patient
71 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
E1: INITIAL REPORTER ADDRESS 1: (B)(6). E1: INITIAL REPORTER PHONE: (B)(6).
Description of Event or Problem
IT WAS REPORTED THAT FILTERWIRE RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CAROTID ARTERY. A 190 CM FILTERWIRE EZ WAS SELECTED FOR USE. DURING PREPARATION, THE PACKAGE WAS UNPACKED AND IT WAS NOTED THAT THE BOTTOM OF THE FILTERWIRE WAS RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.