MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SAMURAI; CATHETER, GUIDEWIRE

Model Number	2842
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a guidewire fracture and removal difficulty occurred.The diffusely stenosed target lesion of less than 30% was located in the moderately tortuous and moderately calcified left circumflex artery.After withdrawal of a balloon, the 190cm straight-tip samurai guidewire was noted to be abnormal and could not be withdrawn.A microcatheter was introduced, but the guidewire was fractured and could not be removed.The device fragment remains inside the patient.The procedure was completed with a different device and the patient was stable.
Additional Manufacturer Narrative
E1.Initial reporter address 1: (b)(6).E1.Initial reporter phone: (b)(6).

• Brand Name: SAMURAI
• Common Device Name: CATHETER, GUIDEWIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 23360676
• Report Number: 2124215-2025-71402
• Device Sequence Number: 18347544
• Product Code: DQX
• UDI-Device Identifier: 08714729881216
• UDI-Public: (01)08714729881216(17)270923(10)34908736
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151840
• 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
• Report Date (Section B): 10/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2842
• Device Catalogue Number: 2842
• Device Lot Number: 0034908736
• 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: 09/29/2025
• Initial Report FDA Received Date: 10/22/2025
• Date Device Manufactured: 09/23/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male