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

Model Number	2842
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that device break occurred.A samurai guidewire was selected for use, as the procedure was finishing the samurai broke in two pieces.The detached samurai guidewire was retrieved from the vessel.The patient was stable, no patient complications were reported.
Event or Problem Description
It was reported that device break occurred.A samurai guidewire was selected for use, as the procedure was finishing the samurai broke in two pieces.The detached samurai guidewire was retrieved from the vessel.The patient was stable, no patient complications were reported.It was further reported that the samurai guidewire was located between the intima of the vessel and the drug eluting stent that was previously placed.The detached wire was removed but the tip remained locked with the previously implanted drug eluting stent.
Additional Manufacturer Narrative
Device evaluated by manufacturer: a samurai guidewire was returned for analysis.The core was fractured at about 20 mm from the distal tip of the wire, and the outer later pt coil and inner layer sus coil were also stretched in the direction of the wire tip from the middle brazing position.It was also observed that the fracture surfaces of the core and coil by electron microscopy revealed dimple characteristics of ductile fracture on both surfaces.The detached distal tip could not be confirmed as it was not returned.
Event or Problem Description
It was reported that device break occurred.A samurai guidewire was selected for use, as the procedure was finishing the samurai broke in two pieces.The detached samurai guidewire was retrieved from the vessel.The patient was stable, no patient complications were reported.It was further reported that the samurai guidewire was located between the intima of the vessel and the drug eluting stent that was previously placed.The detached wire was removed but the tip remained locked with the previously implanted drug eluting stent.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16485370
• Report Number: 2124215-2023-10228
• Device Sequence Number: 17604460
• Product Code: DQX
• UDI-Device Identifier: 08714729881216
• UDI-Public: 08714729881216
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2023

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: 12/14/2025
• Device Model Number: 2842
• Device Catalogue Number: 2842
• Device Lot Number: 0030721690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2023
• Supplement Date Received by Manufacturer: 03/08/2023; 06/01/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 03/24/2023; 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2022
• 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
• Patient Sex: Unknown