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	03/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that device difficult remove occurred.The target lesion was located in the internal carotid artery (stenosis of c1 segment of right internal carotid artery).A 190 cm filterwire was selected for use.During the procedure, the physician noted significant resistance while retracting the filterwire.The filterwire was then smoothly inserted into the body along the long sheath and advanced to the lesion site.The filterwire was slowly delivered to the distal end of the c2 segment to prepare for deployment, however, it was found that the filterwire body could not expand all the time, and repeated attempts failed.The delivery sheath was subsequently withdrawn from the body, and the delivery guidewire was advanced externally.After repeated advancing of the delivery guide wire, the filterwire body was finally pushed out and the physician use the recovery sheath to deploy the filterwire.The filterwire was inserted into the recovery sheath, which was advanced to the y-valve for delivery.Although the device was positioned, the filterwire body still did not expand, and the recovery sheath could not be withdrawn.The recovery sheath and filterwire were removed together from the body and the procedure was completed with another of the same device.There were no patient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).Investigation results: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record: 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.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause traced to device design.
Event or Problem Description
It was reported that device difficult remove occurred.The target lesion was located in the internal carotid artery (stenosis of c1 segment of right internal carotid artery).A 190 cm filterwire was selected for use.During the procedure, the physician noted significant resistance while retracting the filterwire.The filterwire was then smoothly inserted into the body along the long sheath and advanced to the lesion site.The filterwire was slowly delivered to the distal end of the c2 segment to prepare for deployment, however, it was found that the filterwire body could not expand all the time, and repeated attempts failed.The delivery sheath was subsequently withdrawn from the body, and the delivery guidewire was advanced externally.After repeated advancing of the delivery guide wire, the filterwire body was finally pushed out and the physician use the recovery sheath to deploy the filterwire.The filterwire was inserted into the recovery sheath, which was advanced to the y-valve for delivery.Although the device was positioned, the filterwire body still did not expand, and the recovery sheath could not be withdrawn.The recovery sheath and filterwire were removed together from the body and 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: 24747627
• Report Number: 2124215-2026-17696
• Device Sequence Number: 21018744
• Product Code: NFA
• UDI-Device Identifier: 08714729470854
• UDI-Public: (01)08714729470854(17)270115(10)35635711
• 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): 05/04/2026

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: 0035635711
• 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: 03/06/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 05/04/2026
• Date Device Manufactured: 01/15/2025
• 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: 63 YR
• Patient Sex: Unknown
• Patient Weight: 58 KG