MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Samurai RC; Catheter, Guidewire

Model Number	2839
Medical Device Problem Codes	Nonstandard Device (1420); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a coating issue occurred.A samurai rc guidewire was selected for treatment of the target lesion.During the procedure, the guidewire coating began to come off.The device was removed, and another guidewire was used to successfully complete the procedure.There were no patient complications.

• Brand Name: Samurai RC
• 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 ; +1(763)494-1632
• MDR Report Key: 25414279
• Report Number: 2124215-2026-30255
• Device Sequence Number: 5840411
• Product Code: DQX
• UDI-Device Identifier: 08714729886679
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K151840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2026

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 Expiration Date: 10/16/2008
• Device Model Number: 2839
• Device Catalogue Number: 2839
• Device Lot Number: 0037733533
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/25/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2026
• Supplement Date Received by Manufacturer: 08/05/2026
• Initial Report FDA Received Date: 06/05/2026
• Supplement Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2025
• 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 Sex: Unknown