MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FilterWire EZ?; temporary coronary saphenous vein bypass graft for embolic protection

Model Number	H749201001900
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1 - initial reporter facility name: beijing temple of heaven hospital, capital university of medical sciences.E1 - initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that filter was difficult to recapture requiring additional intervention.A 190 cm filter wire ez was selected for use in a carotid artery.During the procedure, it was difficult to withdraw the filter wire, and it was difficult to put it into the recovery sheath.The resistance was obvious, so the filter wire was put into the recovery sheath with the cooperation of the non- boston scientific middle catheter.The procedure was completed with another of the same device.There were no patient complications as a result of this event.The patient was stable post procedure.

• 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(763)494-1632
• MDR Report Key: 25892739
• Report Number: 2124215-2026-39111
• Device Sequence Number: 10017314
• Product Code: NFA
• UDI-Device Identifier: 08714729470854
• UDI-Public: (01)08714729470854(17)270313(10)36063128
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2026

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: 0036063128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2026
• Supplement Date Received by Manufacturer: 07/27/2026
• Initial Report FDA Received Date: 07/21/2026
• Supplement Report FDA Received Date: 08/12/2026
• Date Device Manufactured: 03/13/2025
• 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: 48 YR
• Patient Sex: Male
• Patient Weight: 158 LB