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 or Delayed Positioning (1157); Mechanical Problem (1384); Nonstandard Device (1420); Material Integrity Problem (2978); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name - (b)(6) hospital.E1: initial reported address 1 - (b)(6).
Event or Problem Description
It was reported that handle fractured occurred.The 70% stenosed target lesion was located in the carotid artery.A 190 cm filterwire ez? was selected for use.During preparation to deploy the filterwire, the handle fractured, preventing the filterwire from opening.The device was removed, the procedure was completed using with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
(b)(6).The device was returned for analysis.The guidewire was returned within the delivery sheath, and the filter bag was returned in a deployed state.Visual examination identified that the guidewire was exposed through the delivery sheath and was kinked.Due to the guidewire being exposed through the delivery sheath, sheathing and unsheathing could not be performed.
Event or Problem Description
It was reported that handle fractured occurred.The 70% stenosed target lesion was located in the carotid artery.A 190 cm filterwire ez? was selected for use.During preparation to deploy the filterwire, the handle fractured, preventing the filterwire from opening.The device was removed, the procedure was completed using with another of the same device.There were no patient complications reported.It was further reported that there was no intervention happened when the issue happened.
Additional Manufacturer Narrative
E1: initial reporter facility name - (b)(6).E1: initial reported address 1 - (b)(6).
Event or Problem Description
It was reported that handle fractured occurred.The 70% stenosed target lesion was located in the carotid artery.A 190 cm filterwire ez? was selected for use.During preparation to deploy the filterwire, the handle fractured, preventing the filterwire from opening.The device was removed, the procedure was completed using with another of the same device.There were no patient complications reported.It was further reported that there was no intervention happened when the issue happened.
Event or Problem Description
It was reported that handle fractured occurred.The 70% stenosed target lesion was located in the carotid artery.A 190 cm filterwire ez? was selected for use.During preparation to deploy the filterwire, the handle fractured, preventing the filterwire from opening.The device was removed, the procedure was completed using with another of the same device.There were no patient complications reported.It was further reported that there was no intervention happened when the issue happened.
Additional Manufacturer Narrative
E1: zipcode updated.E1: initial reporter facility name - (b)(6).E1: initial reported address 1 - (b)(6).The device was returned for analysis.The guidewire was returned within the delivery sheath, and the filter bag was returned in a deployed state.Visual examination identified that the guidewire was exposed through the delivery sheath and was kinked.Due to the guidewire being exposed through the delivery sheath, sheathing and unsheathing could not be performed.

• 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: 23457118
• Report Number: 2124215-2025-78719
• Device Sequence Number: 20802180
• Product Code: NFA
• UDI-Device Identifier: 08714729470854
• UDI-Public: (01)08714729470854(17)260722(10)34476092
• 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,Followup,Followup
• Report Date (Section B): 03/26/2026

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: 07/22/2026
• Device Model Number: H749201001900
• Device Catalogue Number: H749201001900
• Device Lot Number: 0034476092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Supplement Date Received by Manufacturer: 11/13/2025; 12/12/2025; 02/28/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/11/2025; 01/07/2026; 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2024
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 67 KG