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	Nonstandard Device (1420); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional event details were not provided to bsc.We completed a good faith effort to obtain the information, but it was unable to be obtained.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the filterwire snapped and fractured.A 190 cm filterwire ez was selected for left heart catheterization.During the procedure, the filterwire snapped and fractured on the device.The procedure was completed with another filterwire.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Updated e1: initial reporter email.Additional event details were not provided to bsc.We completed a good faith effort to obtain the information, but it was unable to be obtained.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the filterwire snapped and fractured.A 190 cm filterwire ez was selected for left heart catheterization.During the procedure, the filterwire snapped and fractured on the device.The procedure was completed with another filterwire.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that the filterwire snapped and fractured.A 190 cm filterwire ez was selected for left heart catheterization.During the procedure, the filterwire snapped and fractured on the device.The procedure was completed with another filterwire.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the filterwire ez device was returned to our post market quality assurance laboratory.Visual inspection was performed and identified that the wire returned inside the delivery sheath and the filter bag came back in deployed state.It is possible to observed that the wire was exposed through the delivery sheath, also the spring tip was bent.This concludes the product analysis.

• 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: 23292563
• Report Number: 2124215-2025-72465
• Device Sequence Number: 16000714
• Product Code: NFA
• UDI-Device Identifier: 08714729470854
• UDI-Public: (01)08714729470854(17)270529(10)36635109
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/08/2025

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: H749201001900
• Device Catalogue Number: H749201001900
• Device Lot Number: 0036635109
• 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: 09/17/2025
• Supplement Date Received by Manufacturer: 09/29/2025; 11/21/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 10/27/2025; 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2025
• 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
• Patient Sex: Unknown