MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FILTERWIRE EZ?; TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION

Model Number	H749201003000
Medical Device Problem Codes	Nonstandard Device (1420); Deformation Due to Compressive Stress (2889); Material Integrity Problem (2978); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2026.It was reported that fileterwire failed to deploy and damage occurred.The 80% stenosed target lesion was located in the moderately tortuous and mild calcified left internal carotid artery.A 300 cm filterwire was selected for use.During the procedure, a bsc 8f guiding catheter to the common carotid artery bifurcation using an angiographic guidewire and catheter, which were then removed.A bsc thrombus protection system was advanced to the c3 segment of the internal carotid artery; however, it was noted that deployment of the filterwire was difficult.After multiple attempts, the proximal end of the filterwire formed a loop in the common carotid artery and still could not be deployed and became severely kinked, preventing further use and delivery through an angiographic catheter.The procedure was completed with another of the same device.There were no patient complications as a result of this event.However, device analysis revealed that the spring tip was detached.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).E1: initial reporter phone: (b)(6).Investigation results: device evaluated by mfr: the pcb device was returned to our post market quality assurance laboratory.The wire returned inside the retrieval sheath and the filter bag came back in undeployed state.The delivery sheath was returned.It is possible to observed that the spring tip was detached.Sheathing/unsheathing could not be performed, since the wire returned inside the retrieval sheath, since the retrieval sheath only has the action of retracting and not deploy.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: 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: 24852036
• Report Number: 2124215-2026-19592
• Device Sequence Number: 18403916
• Product Code: NFA
• UDI-Device Identifier: 08714729470861
• UDI-Public: (01)08714729470861(17)261104(10)35212075
• 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
• Report Date (Section B): 04/10/2026

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 Model Number: H749201003000
• Device Catalogue Number: H749201003000
• Device Lot Number: 0035212075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2024
• 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: 60 YR
• Patient Sex: Unknown
• Patient Weight: 62 KG