MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FILTERWIRE EZ?; TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION

Model Number	H749201003000
Medical Device Problem Codes	Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device difficult to recapture occurred.The stenosed target lesion was located in the internal carotid artery.A 300 cm filterwire was selected for use.It was observed that the filterwire could not be retracted outside the patient.The procedure was completed with another of the same device and there were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).E1: initial reporter phone: (b)(6).
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).E1: initial reporter phine: (b)(6).Device evaluated by mfr: the filterwire was returned for analysis.The wire returned inside the delivery sheath and the filter bag came back in undeployed state.It is possible to observed that the spring tip was bent and stretched.Sheathing/unsheathing test was performed, and the filter bag can be retracted/deployed by normal way.With the available information, boston scientific concludes: investigation results summary: product return status: the device was returned for analysis.Device/media analysis: during its analysis, the functional inspection passed because sheathing/unsheathing test was performed, and the filter bag can be retracted/deployed by normal way, which not confirms the reported filterwire difficult/failure to capture/retrieve filter.Additionally, the visual inspection failed because the spring tip was bent and stretched, which could not have contributed to the reported code.Device history record (dhr) review: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Risk review: a risk review was completed and confirmed that the event of filterwire difficult/failure to capture/retrieve filter, spring tip bent/kinked and stretched were defined in the risk documentation and is documented accordingly in the prr.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: boston scientific concludes the most probable root cause is "device problem excluded".This cause code was selected because the wire returned inside the delivery sheath and the filter bag came back in undeployed state and the sheathing/unsheathing test was performed, and the filter bag can be retracted/deployed by normal way.The bent and the stretch in the spring tip is related to excessive handling of the device and the technique used by the doctor in procedure, which could possibly have affected the performance and integrity of the device.Therefore, the problem found is classified as "adverse event related to procedure".Moreover, a device history record (dhr) review was conducted and no deviations that could have contributed to the reported event were found.All compiled information on this investigation determines that conclusion code is "device problem excluded", since the functional inspection passed and the sheathing/unsheathing test was performed.
Event or Problem Description
It was reported that device difficult to recapture occurred.The stenosed target lesion was located in the internal carotid artery.A 300 cm filterwire was selected for use.It was observed that the filterwire could not be retracted outside the patient.The procedure was completed with another of the same device and there were no patient complications as a result of this event.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 23803884
• Report Number: 2124215-2025-90829
• Device Sequence Number: 18475178
• Product Code: NFA
• UDI-Device Identifier: 08714729470861
• UDI-Public: (01)08714729470861(17)270217(10)35871074
• 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): 03/18/2026

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 Model Number: H749201003000
• Device Catalogue Number: H749201003000
• Device Lot Number: 0035871074
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2025
• 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 Age: 61 YR
• Patient Sex: Male
• Patient Weight: 65 KG