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

Model Number	2842
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2 - age at time of event: patient is 18 years or older.E1 - initial reporter phone: (b)(6).Device evaluated by mfr.: the returned device consisted of the samurai complaint device.A visual examination of the core and coil were ruptured at approximately 0.5 mm from the tip of the wire, and it was confirmed that the tip was missing.Observation of the core and coil at the fracture position confirmed that the fracture surface was characteristic of ductile fracture.We also observed a j-shaped bend at approximately 11 mm from the tip, a gentle bend at 40 mm from the tip, and a hook-shaped bend at approximately 98 mm from the tip.We also observed a coil pitch opening at approximately 4 mm from the tip and a coil tightness of approximately 2mm in width at approximately 87 mm from the tip.Observations were also made on other parts of the product, but no abnormalities were found, and no problems were observed.
Event or Problem Description
Reportable based on device analysis completed on 12may2025.It was reported that a guidewire kinked occurred.A percutaneous intervention procedure was being performed.A 190cm samurai guidewire was used.However, during preparation, it was noticed that the guidewire was already kinked or bent.The procedure was completed with another of the same device without any patient complications reported.However, returned device analysis revealed a distal tip and core wire detached.

• 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: 22150939
• Report Number: 2124215-2025-34762
• Device Sequence Number: 7849644
• Product Code: DQX
• UDI-Device Identifier: 08714729881216
• UDI-Public: (01)08714729881216(17)270205(10)33367713
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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): 06/05/2025

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: 2842
• Device Catalogue Number: 2842
• Device Lot Number: 0033367713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2024
• 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 Sex: Male