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	04/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entrapment occurred.The patient with stenosis at the initial segment of the internal carotid artery underwent percutaneous carotid artery stent implantation under angiographic guidance with a 190 cm filterwire placed across the lesion.The target lesion showed 80% stenosis in a mildly tortuous and moderately calcified carotid artery.A 10.0-31 carotid wallstent was advanced to the target lesion; however, the stent could not be released or withdrawn normally.The stent and delivery system became stuck together and were removed together with the filterwire through an unknown 8f guiding catheter positioned high in the vessel.The device was exchanged, and another filterwire and a 7 x 40 carotid artery stent were used to complete the procedure.No additional maneuvers were required.No challenging anatomy, or other procedural factors were reported to have contributed to the event.There were no patient complications as a result of this event, and the patient was stable post-procedure.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).Good faith effort attempts were made to try and retrieve product status and additional details regarding the reported event, but further information was unable to be obtained.

• 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: 25246690
• Report Number: 2124215-2026-27446
• Device Sequence Number: 9562571
• Product Code: NFA
• UDI-Device Identifier: 08714729470854
• UDI-Public: (01)08714729470854(17)260930(10)34957736
• 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): 07/13/2026

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: 09/30/2026
• Device Model Number: H749201001900
• Device Catalogue Number: H749201001900
• Device Lot Number: 0034957736
• 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: 04/23/2026
• Supplement Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 05/21/2026
• Supplement Report FDA Received Date: 07/13/2026
• Date Device Manufactured: 09/30/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER: 8F.; STENT: 10.0-31 CAROTID WALLSTENT.
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 63 KG