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

Model Number	2842
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that a guidewire fracture occurred.The 83% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending (lad) artery.A 190 cm straight-tip (5pk) was selected for use.However, during the procedure, the guidewire fractured.The device was completed with another of same device.The patient's condition remained stable following the procedure.
Additional Manufacturer Narrative
E1: initial reporter phone:(b)(6).The device was returned for analysis.A visual and tactile inspection revealed a j-shaped bend approximately 7 mm from the tip of the wire, along with a coil pitch discrepancy of about 1 mm, located approximately 8 mm from the tip.Other areas of the device were also examined, but no additional abnormalities or issues were identified.Media inspection consisted of two photos.One image depicted the device outside the body, showing possible stretched coils and a bent tip.The other photo, a fluoroscopy image taken inside the body, showed a device that appeared to be detached.However, the observed damage is most likely due to the stretched coil and bent tip.The media confirmed the reported event and the returned device.The findings from the returned device, specifically the coil pitch discrepancy (stretched coil), were consistent with the details in the reported event and the accompanying media.
Event or Problem Description
It was reported that a guidewire fracture occurred.The 83% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending (lad) artery.A 190 cm straight-tip (5pk) was selected for use.However, during the procedure, the guidewire fractured.The device was completed with another of same device.The patient's condition remained stable following the procedure.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20593580
• Report Number: 2124215-2024-66555
• Device Sequence Number: 8803885
• 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,Followup
• Report Date (Section B): 01/08/2025

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: 0033647216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2024
• 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