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

Model Number	2842
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 17-apr-2025.It was reported that guidewire tip stretched was encountered.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 190cm samurai guidewire was advanced and the guidewire was found to be stretched.The procedure was completed with another of the same device.The patient condition following the procedure was stable.No patient complications were reported.However, returned device analysis revealed core wire detached.
Additional Manufacturer Narrative
Device evaluated by mfr.: the samurai guidewire was returned for analysis.Visual inspection revealed that the core wire was found to have fractured approximately 3 mm from the tip, with the coil stretched toward the distal end.The fracture surface exhibited bending and showed a dimple pattern characteristic of a ductile fracture.No material was missing from either the core or the coil.Additionally, an arc-shaped bend was observed about 19 mm from the tip, along with slight coil pitch elongation between 14-21 mm and 28-33 mm from the tip.No other abnormalities were observed.Media was provided and analyzed.The media consisted of a photo and a video of fluoroscopy during the procedure of the distal end/tip of the wire.The media showed a portion of the tip that appeared lighter, so it was most likely this was the area the coil was stretched.E1: initial reporter facility name: (b)(6).E1: initial reporter address (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: 22003680
• Report Number: 2124215-2025-28272
• Device Sequence Number: 7313758
• Product Code: DQX
• UDI-Device Identifier: 08714729881216
• UDI-Public: 08714729881216
• 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): 05/12/2025

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: 0033783845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2024
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 50 KG