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); Failure to Advance (2524); Material Integrity Problem (2978); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) hospital e1 - initial reporter phone: (b)(6).Device technical analysis: the device was returned for evaluation.The wire returned inside the delivery sheath and the filter bag came back in undeployed state.It is possible to observed that the wire was exposed through the delivery sheath, the guidewire was kinked, moreover the spring tip was detached.Sheathing/unsheathing could not be performed, since the wire was exposed through the delivery sheath.No other issues were identified during the product analysis.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.Risk review a risk review performed for the filterwire ez confirmed that the event of spring tip detached/separated is a known event defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion boston scientific concludes the most probable root cause as cause traced to device design.A potential root cause is misalignment between the design and manufacturing specifications for the filterwire ez filter bag thickness, which causes sheathing and unsheathing resistance.
Event or Problem Description
Reportable based on device analysis completed on 16feb2026.It was reported that filterwire could not be deployed and was deformed.The more than 90% stenosed target lesion was located in the internal carotid artery.A 190 cm filterwire ez was selected for use in a carotid artery stenting.During the procedure, the filteriwre attempted to cross the challenging lesion but failed.Consequently, when attempted to deploy multiple times, it could not be deployed.The filterwire was withdrawn and it was noted that it was deformed.The filterwire was replaced and the procedure was completed.There were no patient complications as a result of this event.However, device analysis revealed spring tip detached.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2026.It was reported that filterwire could not be deployed and was deformed.The more than 90% stenosed target lesion was located in the internal carotid artery.A 190 cm filterwire ez was selected for use in a carotid artery stenting.During the procedure, the filteriwre attempted to cross the challenging lesion but failed.Consequently, when attempted to deploy multiple times, it could not be deployed.The filterwire was withdrawn and it was noted that it was deformed.The filterwire was replaced and the procedure was completed.There were no patient complications as a result of this event.However, device analysis revealed spring tip detached.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).E1 - initial reporter phone: (b)(6).Device technical analysis: the device was returned for evaluation.The wire returned inside the delivery sheath and the filter bag came back in undeployed state.It is possible to observed that the wire was exposed through the delivery sheath, the guidewire was kinked, moreover the spring tip was unraveled and fractured.Sheathing/unsheathing could not be performed, since the wire was exposed through the delivery sheath.No other issues were identified during the product analysis.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 traced to device design.

• 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: 24583570
• Report Number: 2124215-2026-13954
• Device Sequence Number: 10355682
• Product Code: NFA
• UDI-Device Identifier: 08714729470854
• UDI-Public: (01)08714729470854(17)260923(10)34911686
• 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): 04/16/2026

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: 09/23/2026
• Device Model Number: H749201001900
• Device Catalogue Number: H749201001900
• Device Lot Number: 0034911686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2024
• 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: 77 YR
• Patient Sex: Male
• Patient Weight: 82 KG