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); Material Integrity Problem (2978); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6) university.E1: initial reporter phone: (b)(6).Device evaluated by mfr: visual inspection revealed that the wire was returned inside the retrieval sheath and the filter bag came back in undeployed state.It is possible to observed that the spring tip was kinked and the delivery sheath was detached.Functional testing could not be performed since the delivery sheath was detached.
Event or Problem Description
Reportable based on device analysis completed on 24oct2025.It was reported that the filter wire failed to deploy and damaged occurred.The stenosed target lesion was located in the internal carotid artery.A 190 cm filter wire was selected for use.During the procedure, the filter wire could not be deployed and a fracture was noted at one-third of its length in the sheath.The procedure was completed with another of the same device.There were no patient complications as a result of this event.However, returned device analysis revealed a delivery sheath detached.
Event or Problem Description
Reportable based on device analysis completed on 24oct2025.It was reported that the filter wire failed to deploy and damaged occurred.The stenosed target lesion was located in the internal carotid artery.A 190 cm filter wire was selected for use.During the procedure, the filter wire could not be deployed, and damage was noted at one-third of its length in the sheath.The procedure was completed with another of the same device.There were no patient complications as a result of this event.However, returned device analysis revealed a delivery sheath detached.
Additional Manufacturer Narrative
E1: (b)(6).Investigation results summary: product return status: the device was returned for analysis.Device/media analysis: during its analysis, functional inspection could not be performed, since the delivery sheath was detached.The reported filter difficult to deploy could not be confirmed.However, the reported filter difficult to deploy was able to be confirmed.Additionally, visual inspection did not pass due to the spring tip was kinked and stretched.Moreover, the delivery sheath was detached, which could have contributed to the reported filterwire damaged/defective.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.Risk review: a risk review was completed and confirmed that the event of filterwire damaged/defective, filter difficult to deploy, filterwire detached/separated and spring tip bent/kinked were defined in the risk 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.This cause was selected to addresses resistance issues during deployment of the filterwire device.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.The reported filterwire damaged/defective is associated with the spring tip kinked, stretched and the delivery sheath detached, found during the product analysis, and may be related with some other factors such as; excessive handling of the device, the technique used by the physician and normal procedural difficulties encountered during the procedure that could have possibly affected the device performance and its integrity, moreover a device history record (dhr) review was conducted and no deviations that could have contributed to the reported event were found.All compiled information determined that the overall conclusion was 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23606841
• Report Number: 2124215-2025-83461
• Device Sequence Number: 13223726
• Product Code: NFA
• UDI-Device Identifier: 08714729470854
• UDI-Public: (01)08714729470854(17)260730(10)34541039
• 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): 03/18/2026

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: 07/30/2026
• Device Model Number: H749201001900
• Device Catalogue Number: H749201001900
• Device Lot Number: 0034541039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2024
• 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: 68 KG