MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FilterWire EZ?; temporary coronary saphenous vein bypass graft for embolic protection

Model Number	H749201001900
Medical Device Problem Codes	Difficult or Delayed Activation (2577); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that the filterwire was fractured.During a carotid artery stenting procedure, an 8fr x 90 cm sheath was used to deliver a 190 cm filterwire ez; however, the device could not be deployed.Following recapture, fracture of the filterwire guidewire was identified.The procedure was successfully completed with another of the same device and the issue was resolved.No patient complications occurred as a result of this event, and the patient was stable post-procedure.

• Brand Name: FilterWire EZ?
• Common Device Name: temporary coronary saphenous vein bypass graft for embolic protection
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Corporation; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(763)494-1632
• MDR Report Key: 25595466
• Report Number: 2124215-2026-33304
• Device Sequence Number: 20178977
• Product Code: NFA
• UDI-Device Identifier: 08714729470854
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K063313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H749201001900
• Device Catalogue Number: H749201001900
• Device Lot Number: 0035927275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2026
• Supplement Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 06/23/2026
• Supplement Report FDA Received Date: 09/09/2026
• Date Device Manufactured: 02/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTRODUCER SHEATH: 8FR X 90CM
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 167 LB