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	Difficult to Remove (1528); 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	07/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that removal difficulty occurred.The 70% stenosed target lesion was located in the mildly calcified and mildly tortuous carotid artery.A 190 cm filterwire was prepared outside the patient.The filter was deployed and recaptured into the delivery sheath in a saline bath without issue.A long sheath was positioned and the filterwire was then advanced in the patient to the target location.During deployment, significant resistance was encountered, and the filter could not be completely deployed.The physician attempted to recapture the filter, but retrieval was difficult.The filterwire was withdrawn using the long sheath, and the pushing guidewire was found to be kinked and deformed.The procedure was completed with a non-bsc device.The patient remained stable following the procedure, and no patient complications were reported as a result of this event.
Event or Problem Description
It was reported that removal difficulty occurred.The 70% stenosed target lesion was located in the mildly calcified and mildly tortuous carotid artery.A 190 cm filterwire was prepared outside the patient.The filter was deployed and recaptured into the delivery sheath in a saline bath without issue.A long sheath was positioned and the filterwire was then advanced in the patient to the target location.During deployment, significant resistance was encountered, and the filter could not be completely deployed.The physician attempted to recapture the filter, but retrieval was difficult.The filterwire was withdrawn using the long sheath, and the pushing guidewire was found to be kinked and deformed.The procedure was completed with a non-bsc device.The patient remained stable following the procedure, and no patient complications were reported as a result of this event.
Additional Manufacturer Narrative
E1: initial reporter city -(b)(6)e1: initial reporter facility number -(b)(6).Detailed information was not provided to bsc.A good-faith effort was made to acquire the necessary information.Since we are unable to provide specific details at this time, a supplemental report will be submitted if additional information becomes available in the future.
Additional Manufacturer Narrative
E1: initial reporter facility number - (b)(6).Investigation results: device history records (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, the most probable cause for this complaint 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50254227
• Report Number: 2124215-2026-43675
• Device Sequence Number: 10141649
• Product Code: NFA
• UDI-Device Identifier: 08714729470854
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K063313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H749201001900
• Device Catalogue Number: H749201001900
• Device Lot Number: 0035927275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2026
• Supplement Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 08/14/2026
• Supplement Report FDA Received Date: 09/15/2026
• Date Device Manufactured: 02/24/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Unknown