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

Model Number	2842
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a tip fracture occurred.The 90 degree angle target lesion was located in the circumflex.A 190cm samurai guidewire was advanced, but the tip fractured after advancement past the lesion.An attempt to snare the fractured tip with a goose neck snare was made, but it was unsuccessful.The device was removed, however, the tip portion of the device remained inside the patient.The procedure was completed with another device.No patient complications were reported in relation to this event.
Event or Problem Description
It was reported that a tip fracture occurred.The target lesion was located in the circumflex.A 190cm samurai guidewire was advanced, but the tip fractured at the circumflex.An attempt to snare the fractured tip with a goose neck snare was made, but it was unsuccessful.The device was removed, but was not intact.The tip portion of the device remained inside the patient.The procedure was completed with another device.No patient complications were reported in relation to this event.It was further reported that the target lesion located in the circumflex had a 90 degree angle, and was not calcified.
Event or Problem Description
It was reported that a tip fracture occurred.The target lesion was located in the circumflex.A 190cm samurai guidewire was advanced, but the tip fractured at the circumflex.An attempt to snare the fractured tip with a goose neck snare was made, but it was unsuccessful.The device was removed, but was not intact.The tip portion of the device remained inside the patient.The procedure was completed with another device.No patient complications were reported in relation to this event.It was further reported that the target lesion located in the circumflex had a 90 degree angle, and was not calcified.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for analysis.As a result of observing the returned product, it was confirmed that the core, coil and in coil were broken at a position of about 40 mm from the distal tip, and that part of the tip was missing.In addition, as a result of observing the fracture surface with an electron microscope, dimples, which are a characteristic of ductile fracture were noted.Other parts of the product conformed to manufacturing standards, and no abnormalities could be confirmed.

• Brand Name: SAMURAI
• Common Device Name: CATHETER, GUIDEWIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13185253
• Report Number: 2134265-2021-16527
• Device Sequence Number: 2032785
• Product Code: DQX
• UDI-Device Identifier: 08714729881216
• UDI-Public: 08714729881216
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/23/2022

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 Expiration Date: 07/22/2024
• Device Model Number: 2842
• Device Catalogue Number: 2842
• Device Lot Number: 0027724581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/16/2021
• Supplement Date Received by Manufacturer: 12/28/2021; 02/28/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 01/20/2022; 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2021
• 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; Other
• Patient Sex: Unknown