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); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 06nov2025.It was reported that the filterwire failed to deploy.A patient underwent a left-sided percutaneous carotid artery balloon dilation and stenting procedure, which included stent implantation under a cerebral filterwire and full cerebral angiography.The target lesion, with more than 70% stenosis, was located at the c1 opening of the left internal carotid artery.A 190cm filterwire was advanced into the target lesion for internal carotid artery stenting.When reaching c2 segment of left internal carotid artery, upon deployment, it was noted that the filterwire could not be deployed despite multiple attempts.The physician withdrew the protection system along the vessel and attempted to deploy it in an extracorporeal environment, but high resistance persisted, and the guidewire became deformed.Although the filterwire was eventually pushed out, it could not fully expand and was deemed unusable for thrombus capture.The procedure was completed using a different device.However, device analysis revealed the spring tip and all section of the filter including the nosecone were detached.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).Device evaluated by mfr: the device was returned for evaluation.Media inspection revealed that the filterwire was kinked.The wire returned inside the delivery sheath and the filter bag came back in deployed state.It is possible to observe that the delivery sheath was kinked at the proximal section.The spring tip was detached.All section of the filter including the nosecone was detached.Sheathing/unsheathing could not be performed, since all section of the fitter including the nosecone was detached.No other issues were identified with the device.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).H6 - evaluation method codes: updated with the available information, boston scientific concludes: 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.Device technical analysis: the device was returned for evaluation.Media inspection revealed that the filterwire was kinked.The wire returned inside the delivery sheath and the filter bag came back in deployed state.It is possible to observe that the delivery sheath was kinked at the proximal section.The spring tip was detached.All section of the filter including the nosecone was detached.Sheathing/unsheathing could not be performed, since all section of the fitter including the nosecone was detached.No other issues were identified with the device.Risk review a risk review was completed and confirmed that the event of delivery sheath kinked, spring tip detached/separated and filterwire detached/separated were defined in the risk documentation and is documented accordingly in the prr.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.During the product analysis, it was possible to observed that the delivery sheath was kinked at the proximal section, the spring tip was detached and all section of the filter including the nosecone was detached, it 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.
Event or Problem Description
Reportable based on device analysis completed on 06nov2025.It was reported that the filterwire failed to deploy.A patient underwent a left-sided percutaneous carotid artery balloon dilation and stenting procedure, which included stent implantation under a cerebral filterwire and full cerebral angiography.The target lesion, with more than 70% stenosis, was located at the c1 opening of the left internal carotid artery.A 190cm filterwire was advanced into the target lesion for internal carotid artery stenting.When reaching c2 segment of left internal carotid artery, upon deployment, it was noted that the filterwire could not be deployed despite multiple attempts.The physician withdrew the protection system along the vessel and attempted to deploy it in an extracorporeal environment, but high resistance persisted, and the guidewire became deformed.Although the filterwire was eventually pushed out, it could not fully expand and was deemed unusable for thrombus capture.The procedure was completed using a different device.However, device analysis revealed the spring tip and all section of the filter including the nosecone were detached.

• 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: 23708883
• Report Number: 2124215-2025-85671
• Device Sequence Number: 18798811
• Product Code: NFA
• UDI-Device Identifier: 08714729470854
• UDI-Public: (01)08714729470854(17)260212(10)33412499
• 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): 03/10/2026

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: 02/12/2026
• Device Model Number: H749201001900
• Device Catalogue Number: H749201001900
• Device Lot Number: 0033412499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2024
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 50 KG