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	Mechanical Problem (1384); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(4).Device evaluated by mfr: the filter wire device was returned for evaluation.The wire returned separated from the delivery sheath, and the sheath was in good condition.However, the filter bag is fully detached and did not return.Also, the wire returned kinked in different sections, and the spring tip is kinked as well.However, the wire was not exposed through the sheath.The device was inspected under magnification, and it was possible to see that the filter bag is fully detached.Also, the spring tip is kinked.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 16jan2026.It was reported that the wire was exposed through the sheath slit.A 190 cm filterwire ez was selected for use.During preparation, upon flushing, it was found out that the wire was exposed through the sheath slit.The procedure was completed with another of the same device.There were no patient complications as a result of this event.However, device analysis revealed filter bag detached.
Event or Problem Description
Reportable based on device analysis completed on 16jan2026.It was reported that the wire was exposed through the sheath slit.A 190 cm filterwire ez was selected for use.During preparation, upon flushing, it was found out that the wire was exposed through the sheath slit.The procedure was completed with another of the same device.There were no patient complications as a result of this event.However, device analysis revealed filter bag detached.
Additional Manufacturer Narrative
E1: (b)(6).H6: evaluation conclusion codes: updated.With the available information, boston scientific concludes: device history record (dhr) review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Device technical analysis: the filter wire device was returned for evaluation.The wire returned separated from the delivery sheath, and the sheath was in good condition.However, the filter bag is fully detached and did not return.Also, the wire returned kinked in different sections, and the spring tip is kinked as well.However, the wire was not exposed through the sheath.The device was inspected under magnification, and it was possible to see that the filter bag is fully detached.Also, the spring tip is kinked.No other issues were identified during the product analysis.Risk review: a risk review was completed and confirmed that the event of filterwire wire exposed through sheath slit, filter detached/separated, guidewire bent/kinked and spring tip bent/kinked 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 as device problem excluded because after visual inspection and microscope inspections in the complaint device, it was not possible to identify any evidence of the alleged issue on the device since the wire was not exposed through the sheath.Also, the evidence from the product record review did not identify a potential product quality issue.

• 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: 24332298
• Report Number: 2124215-2026-08083
• Device Sequence Number: 4811073
• Product Code: NFA
• UDI-Device Identifier: 08714729470854
• UDI-Public: (01)08714729470854(17)270122(10)35686099
• 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): 03/12/2026

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: 0035686099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2025
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 78 KG