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

Model Number	H749201001900
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).E1: initial reporter phone: (b)(6).
Event or Problem Description
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.
Event or Problem Description
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.It was further reported that the filter bag was ruptured.It was further reported that the packaging was undamaged and it was found to be malfunctioned before entering the patient.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6) b5: describe event or problem: updated investigation results: media analysis: the media attached to the parent record shows the filter bag torn and in deployed state.Device history record: review confirmed that the device met all material, assembly, and performance specifications prior to distribution.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.

• 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(612)875-7234
• MDR Report Key: 25738412
• Report Number: 2124215-2026-36344
• Device Sequence Number: 13400483
• Product Code: NFA
• UDI-Device Identifier: 08714729470854
• UDI-Public: (01)08714729470854(17)261204(10)35419796
• 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,Followup
• Report Date (Section B): 10/01/2026

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: 0035419796
• 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: 06/11/2026
• Supplement Date Received by Manufacturer: Not provided; 09/10/2026
• Initial Report FDA Received Date: 07/07/2026
• Supplement Report FDA Received Date: 08/19/2026; 10/01/2026
• Date Device Manufactured: 12/04/2024
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 193 LB