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

Model Number	H749201001900
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire fracture occurred.The 90% stenosed target lesion was located in the internal carotid artery.A 190 cm filterwire was selected for use in an internal carotid artery stenting.After unpacking the device, it was found that the front end of the guidewire was broken.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 facility name: (b)(6).E1 - initial reporter address 1: e1 - initial reporter phone:.
Event or Problem Description
It was reported that guidewire fracture occurred.The 90% stenosed target lesion was located in the internal carotid artery.A 190 cm filterwire was selected for use in an internal carotid artery stenting.After unpacking the device, it was found that the front end of the guidewire was broken.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
H6 - evaluation conclusion codes: updated.(b)(6).
Event or Problem Description
It was reported that guidewire fracture occurred.The 90% stenosed target lesion was located in the internal carotid artery.A 190 cm filterwire was selected for use in an internal carotid artery stenting.After unpacking the device, it was found that the front end of the guidewire was broken.The procedure was completed with another of the same device.There were no patient complications as a result of this event.It was further reported that the coating on the tip of the filterwire had fallen off.
Additional Manufacturer Narrative
B5.Describe event or problem: added information, based on additional information.E1 - initial reporter facility name: (b)(6).E1 - initial reporter address 1: (b)(6).E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that guidewire fracture occurred.The 90% stenosed target lesion was located in the internal carotid artery.A 190 cm filterwire was selected for use in an internal carotid artery stenting.After unpacking the device, it was found that the front end of the guidewire was broken.The procedure was completed with another of the same device.There were no patient complications as a result of this event.It was further reported that the coating on the tip of the filterwire had fallen off.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).E1 - initial reporter address 1: (b)(6).E1 - initial reporter phone: (b)(6).Investigation results: device evaluated by mfr: the filterwire device was returned to our post market quality assurance laboratory.The wire returned inside the delivery sheath and the filter bag came back in undeployed state.It is possible to observed that the wire was exposed through the delivery sheath.Sheathing/unsheathing could not be performed, since the wire was exposed through the delivery sheath.This concludes the product analysis.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.Labeling review: review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Risk review: a risk review performed for the filter wire device confirmed that the reported event is a known event defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefits for the product.Investigation conclusion: the as analyzed cause code selected for the as reported code filterwire damage upon removal from package is unable to exclude device problem.According to the customer's report, the issue was discovered during unpacking.As a result, there is insufficient objective evidence or descriptive information to establish a definitive cause for wire exposed through the delivery sheath observed during product analysis.Additionally, the lack of returned device for further evaluation limits the investigation.Therefore, based on all compiled information, the most appropriate conclusion is unable to exclude device problem.

• 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: 24028410
• Report Number: 2124215-2026-01707
• Device Sequence Number: 9014701
• Product Code: NFA
• UDI-Device Identifier: 08714729470854
• UDI-Public: (01)08714729470854(17)261021(10)35111374
• 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,Followup
• Report Date (Section B): 04/02/2026

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: 0035111374
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 01/16/2026; 02/05/2026; 03/09/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 02/12/2026; 03/03/2026; 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2024
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 63 KG