FILTERWIRE EZ
Received Jun 16, 2026 · Event occurred May 15, 2026
Report 2124215-2026-32171 · MDR key 25524954
Device
Generic name
Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Manufacturer
Boston Scientific CorporationModel number
44150Catalog number
44150
Lot number
0035820510
Product problems
- Difficult to Remove
Patient
NA · Female
- 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 DEVICE REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 190 CM MT FILTERWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE PEEL AWAY SHEATH COULD NOT BE REMOVED AND WAS STUCK IN THE SHEATH THUS LEADING TO THE NON DEPLOYMENT OF THE FILTERWIRE. THE PROCEDURE WAS COMPLETED WITH ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.