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	Nonstandard Device (1420); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
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 the filterwire could not be retracted.The target lesion was located in the internal carotid artery stenosis.A 190 cm filterwire ez was selected for use for this stenting procedure.During the procedure, the filterwire could not be retracted.The procedure was completed with a different device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1 - initial reporter address 1: / e1 - initial reporter phone: (b)(6).Investigation results: device evaluated by mfr: the filterwire ez? device was returned to our post market quality assurance laboratory.The wire was returned inside the delivery sheath, and the filter bag came back in an undeployed state.It was observed that the wire was exposed through the delivery sheath, the spring tip was bent and stretched, and the guidewire was kinked.Sheathing/unsheathing could not be performed, since the wire was exposed through the delivery sheath.Device history record: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Investigation conclusion: boston scientific concludes the most probable root cause as adverse event related to procedure.
Event or Problem Description
It was reported that the filterwire could not be retracted.The target lesion was located in the internal carotid artery stenosis.A 190 cm filterwire ez? was selected for use for this stenting procedure.During the procedure, the filterwire could not be retracted.The procedure was completed with a different device.There were no patient complications as a result of this event.

• 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: 24262101
• Report Number: 2124215-2026-06505
• Device Sequence Number: 9649316
• Product Code: NFA
• UDI-Device Identifier: 08714729470854
• UDI-Public: (01)08714729470854(17)270313(10)36063128
• 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): 03/25/2026

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: 0036063128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2025
• 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
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 70 KG