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 to Remove (1528); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that device difficult to remove occurred.The target lesion was located in the c1 segment of right internal carotid artery.A 190 cm filterwire was selected for use.During the procedure, during the procedure, the filter wire was removed and placed into the delivery sheath while submerged in a saline basin, the physician noticed significant resistance when handling the filter wire.The system was then advanced through the long sheath to the target lesion, and the filter wire was slowly delivered to the distal end of the c2 segment in preparation for deployment.The physician used the matching twist controller to enter the delivery guidewire, secured it at the y-valve of the long sheath, and then slowly pull back the delivery sheath.However, it was observed that the filter wire failed to open despite multiple attempts.Then the delivery sheath was withdrawn to the outside of the body, and the delivery guidewire was pushed outside the body.After repeated attempts, the filter wire was finally pushed out, and the physician decided to use the recovery sheath to release the filter wire.After the filterwire was released, it was found that the recovery sheath could not be withdrawn, and the filter wire could not be opened.Both the recovery sheath and the filter wire were subsequently removed from the body.And it was observed that the distal sheath body of the recovery sheath was deformed and could not push and pull the filter wire.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).E1: initial reporter email: updated.Device history records (dhr): 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.Device technical analysis: the device was not received for analysis despite multiple inquiries regarding return status.The reported retrieval sheath difficult to remove is not confirmed since it did not include a returned device or media review to identify any issue that confirms the reported allegation.Investigation conclusion: boston scientific concludes the most probable root cause as cause traced to device design.It was reported that retrieval sheath difficult to remove.The reported issue "retrieval sheath difficult to remove" could not be established due to lack of evidence.Manufacturing documentation review did not identify any issues related to the reported complaint.The product was not returned for analysis, and without proper evaluation, the most probable causes remain unknown; therefore, the investigation cannot definitively confirm or exclude a device-related problem, therefore will be classified an "unable to exclude device problem".
Event or Problem Description
It was reported that device difficult to remove occurred.The target lesion was located in the c1 segment of right internal carotid artery.A 190 cm filterwire was selected for use.During the procedure, during the procedure, the filter wire was removed and placed into the delivery sheath while submerged in a saline basin, the physician noticed significant resistance when handling the filter wire.The system was then advanced through the long sheath to the target lesion, and the filter wire was slowly delivered to the distal end of the c2 segment in preparation for deployment.The physician used the matching twist controller to enter the delivery guidewire, secured it at the y-valve of the long sheath, and then slowly pull back the delivery sheath.However, it was observed that the filter wire failed to open despite multiple attempts.Then the delivery sheath was withdrawn to the outside of the body, and the delivery guidewire was pushed outside the body.After repeated attempts, the filter wire was finally pushed out, and the physician decided to use the recovery sheath to release the filter wire.After the filterwire was released, it was found that the recovery sheath could not be withdrawn, and the filter wire could not be opened.Both the recovery sheath and the filter wire were subsequently removed from the body.And it was observed that the distal sheath body of the recovery sheath was deformed and could not push and pull the filter wire.The procedure was completed with another of the same device.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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24416519
• Report Number: 2124215-2026-09878
• Device Sequence Number: 13413107
• Product Code: NFA
• UDI-Device Identifier: 08714729470854
• UDI-Public: (01)08714729470854(17)270109(10)35594726
• 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): 03/25/2026

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: H749201001900
• Device Catalogue Number: H749201001900
• Device Lot Number: 0035594726
• 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: 01/27/2026
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2025
• 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: 76 YR
• Patient Sex: Unknown
• Patient Weight: 56 KG