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 phone number - (b)(6).
Event or Problem Description
It was reported that the filterwire is difficult to remove.The target lesion was located in the internal carotid artery.A 190 cm filterwire ez? was selected for use.During the procedure, the filter wire could not be retracted.The procedure was subsequently completed using another device of the same type.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
E1: initial reporter phone number - (b)(6).Device evaluation by manufacturer: the device was returned for analysis.The wire was received within the delivery sheath, and the filter bag was in an undeployed state.It was observed that the wire was exposed through the delivery sheath and the spring tip was bent.During analysis, functional inspection of sheathing/unsheathing could not be performed as the wire was exposed through the delivery sheath, confirming the reported filterwire difficult to remove.Visual inspection identified a bent spring tip; however, this condition is not considered contributory to the reported event.Device history record (dhr) review: 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: based on the complaint review, the most probable cause was adverse event related to procedure.Product analysis showed the wire exposed through the delivery sheath, consistent with excessive handling and procedural technique causing opposing forces during use.A bent spring tip was also observed, likely related to procedural factors and normal use conditions.A device history record (dhr) review identified no contributing manufacturing deviations.
Event or Problem Description
It was reported that the filterwire is difficult to remove.The target lesion was located in the internal carotid artery.A 190 cm filterwire ez? was selected for use.During the procedure, the filter wire could not be retracted.The procedure was subsequently completed using another device of the same type.No patient complications were reported 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 MA ; CS
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24278330
• Report Number: 2124215-2026-06489
• Device Sequence Number: 21297668
• Product Code: NFA
• UDI-Device Identifier: 08714729470854
• UDI-Public: (01)08714729470854(17)270211(10)35832586
• 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: 0035832586
• 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: 02/06/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2025
• 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