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 Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1, initial reporter phone:(b)(6).
Event or Problem Description
It was reported that delivery sheath was torn.The target lesion was located in the internal carotid artery.A 190 cm filterwire ez was selected for use.During normal flushing ang upon recovery of the filterwire into the delivery sheath, it was noted that the delivery sheath was torn.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
B5.Describe event or problem: added information, based on additional information.E1- initial reporter phone: (b)(6).Device history record (dhr) review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Investigation conclusion based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.
Event or Problem Description
It was reported that delivery sheath was torn.The target lesion was located in the internal carotid artery.A 190 cm filterwire ez was selected for use.During normal flushing ang upon recovery of the filterwire into the delivery sheath, it was noted that the delivery sheath was torn.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 implanted sheath was torn.

• 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: 24670565
• Report Number: 2124215-2026-15928
• Device Sequence Number: 5067317
• Product Code: NFA
• UDI-Device Identifier: 08714729470854
• UDI-Public: (01)08714729470854(17)260319(10)33663814
• 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,Followup
• Report Date (Section B): 04/17/2026

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 Expiration Date: 03/19/2026
• Device Model Number: H749201001900
• Device Catalogue Number: H749201001900
• Device Lot Number: 0033663814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 04/17/2026
• Date Device Manufactured: 03/19/2024
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 67 KG