MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FILTERWIRE EZ?; TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION

Model Number	H749201003000
Medical Device Problem Codes	Nonstandard Device (1420); Difficult to Advance (2920); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter address 1:(b)(6).E1 - initial reporter phone: device evaluated by mfr: the filterwire device was returned to our post market quality assurance laboratory.Visual inspection was performed and identified that the delivery sheath and the filter bag returned in deployed state.The rotating hemostasis valve (rhv) was returned, and the filterwire system was stuck inside the rhv.It was observed that the spring tip was detached.The wire was exposed through the delivery sheath, and the guidewire and the delivery sheath were kinked.This concludes the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 20nov2025.The target lesion was located in the left internal carotid artery.A 300 cm filterwire ez? was selected for use.During the procedure, the filterwire could not come out during advancement.After the whole filterwire was withdrawn, the whole delivery shaft was deformed.The procedure was completed with another of the same device.There were no patient complications as a result of this event.However, device analysis revealed a detached spring tip.

• 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 ; 7634941632
• MDR Report Key: 23769778
• Report Number: 2124215-2025-87487
• Device Sequence Number: 9742770
• Product Code: NFA
• UDI-Device Identifier: 08714729470861
• UDI-Public: (01)08714729470861(17)260723(10)34491864
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K063313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/10/2025

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 Expiration Date: 07/23/2026
• Device Model Number: H749201003000
• Device Catalogue Number: H749201003000
• Device Lot Number: 0034491864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2024
• 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
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 72 KG