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); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulty occurred.The over 85% stenosed target lesion was located in the internal carotid artery.A 190 cm filterwire ez? was selected for use.However, during the retrieval of the device, the retrieval was difficult and sticky, and it could not be retracted into the sheath.The physician repeatedly tried to pull the filter guidewire forcefully to retrieve it back into the sheath.The filterwire ez? was ultimately exchanged, and the device was positioned 2 cm distal to the lesion.A 4.0 x 30 mm balloon catheter was advanced over the filterwire ez? and inflated for dilation.Post-dilation angiography was performed, and the balloon was withdrawn.Subsequently, a 7.0 x 40 mm wallstent was deployed over the filterwire ez?.Angiography confirmed successful stent deployment with optimal positioning, and the procedure was completed.There were no patient complications as a result of this event, and the patient was stable post-procedure.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).E1 - initial reporter phone: (b)(6).
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).E1 - initial reporter phone: (b)(6).Device evaluated by mfr: the filterwire ez?device was returned to our post market quality assurance laboratory.Visual inspection was performed and revealed that the wire returned inside the retrieval sheath, and the filter bag came back in deployed state.A kink and stretched were observed in the spring tip.Functional inspection was performed and revealed that sheathing/unsheathing could not be performed, since in the retrieval sheath it can only be retracted, because it does not have a deploy function.This concludes the product analysis.
Event or Problem Description
It was reported that removal difficulty occurred.The over 85% stenosed target lesion was located in the internal carotid artery.A 190 cm filterwire ez? was selected for use.However, during the retrieval of the device, the retrieval was difficult and sticky, and it could not be retracted into the sheath.The physician repeatedly tried to pull the filter guidewire forcefully to retrieve it back into the sheath.The filterwire ez? was ultimately exchanged, and the device was positioned 2 cm distal to the lesion.A 4.0 x 30 mm balloon catheter was advanced over the filterwire ez? and inflated for dilation.Post-dilation angiography was performed, and the balloon was withdrawn.Subsequently, a 7.0 x 40 mm wallstent was deployed over the filterwire ez?.Angiography confirmed successful stent deployment with optimal positioning, and the procedure was completed.There were no patient complications as a result of this event, and the patient was stable post-procedure.
Additional Manufacturer Narrative
A1 - patient identifier: updated.(b)(6).Device evaluated by mfr: the filterwire ez?device was returned to our post market quality assurance laboratory.Visual inspection was performed and revealed that the wire returned inside the retrieval sheath, and the filter bag came back in deployed state.A kink and stretched were observed in the spring tip.Functional inspection was performed and revealed that sheathing/unsheathing could not be performed, since in the retrieval sheath it can only be retracted, because it does not have a deploy function.This concludes the product analysis.
Event or Problem Description
It was reported that removal difficulty occurred.The over 85% stenosed target lesion was located in the internal carotid artery.A 190 cm filterwire ez? was selected for use.However, during the retrieval of the device, the retrieval was difficult and sticky, and it could not be retracted into the sheath.The physician repeatedly tried to pull the filter guidewire forcefully to retrieve it back into the sheath.The filterwire ez? was ultimately exchanged, and the device was positioned 2 cm distal to the lesion.A 4.0 x 30 mm balloon catheter was advanced over the filterwire ez? and inflated for dilation.Post-dilation angiography was performed, and the balloon was withdrawn.Subsequently, a 7.0 x 40 mm wallstent was deployed over the filterwire ez?.Angiography confirmed successful stent deployment with optimal positioning, and the procedure was completed.There were no patient complications as a result of this event, and 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 ; 7634941632
• MDR Report Key: 22978402
• Report Number: 2124215-2025-61210
• Device Sequence Number: 9391341
• Product Code: NFA
• UDI-Device Identifier: 08714729470854
• UDI-Public: (01)08714729470854(17)260917(10)34869651
• 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
• Report Date (Section B): 02/19/2026

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: 09/17/2026
• Device Model Number: H749201001900
• Device Catalogue Number: H749201001900
• Device Lot Number: 0034869651
• 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: 08/08/2025
• Supplement Date Received by Manufacturer: 11/05/2025; 01/26/2026
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 12/02/2025; 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2024
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 65 KG