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

Model Number	2846
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the distal tip of the guidewire detached and remained in the patient.A 190cm samurai guidewire was selected for use in a percutaneous coronary intervention (pci).The target lesion was 40% stenosed in the mildly tortuous and moderately calcified ostium of a diagonal branch of the left anterior descending artery (lad).The guidewire was used to deliver a stent and it became stuck in the coronary after the stent deployed and retrieval was attempted.The physician tried to push the device distally in the vessel but movement was not successful.The device was attempted to be pulled, however resistance was noted, and a balloon was advanced in order to attempt to move the device, without success.A further attempt was made to pull harder, however, the guidewire broke along the radiopaque portion, at around 3 cm from the tip.The proximal part of the guidewire was pulled out, and removed successfully.The distal portion of the guidewire was left inside the coronary of the patient.The procedure was successfully completed with an additional stent and non-boston scientific guidewire.An additional stent was placed in the left main in order to keep the detached portion of guidewire stable in the coronary.Unfortunately, the patient will need dapt (dual antiplatelet therapy) for life, due to the piece of guidewire left inside.There were no patient complications reported.The patient was fine and was going home.
Event or Problem Description
It was reported that the distal tip of the guidewire detached and remained in the patient.A 190cm samurai guidewire was selected for use in a percutaneous coronary intervention (pci).The target lesion was 40% stenosed in the mildly tortuous and moderately calcified ostium of a diagonal branch of the left anterior descending artery (lad).The guidewire was used to deliver a stent and it became stuck in the coronary after the stent deployed and retrieval was attempted.The physician tried to push the device distally in the vessel but movement was not successful.The device was attempted to be pulled, however resistance was noted, and a balloon was advanced in order to attempt to move the device, without success.A further attempt was made to pull harder, however, the guidewire broke along the radiopaque portion, at around 3 cm from the tip.The proximal part of the guidewire was pulled out, and removed successfully.The distal portion of the guidewire was left inside the coronary of the patient.The procedure was successfully completed with an additional stent and non-boston scientific guidewire.An additional stent was placed in the left main in order to keep the detached portion of guidewire stable in the coronary.Unfortunately, the patient will need dapt (dual antiplatelet therapy) for life, due to the piece of guidewire left inside.There were no patient complications reported.The patient was fine and was going home.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the samurai, 190cm, straight-tip was returned for evaluation.Observation of the product revealed that the core was severed at about 20 mm from the distal tip.Also, at about 40 mm from the distal tip, the platinum and inner stainless-steel coils were stretched in the direction of the tip and severed.The tip of the wire was missing.The reported event was 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15085588
• Report Number: 2124215-2022-26831
• Device Sequence Number: 3879330
• Product Code: DQX
• UDI-Device Identifier: 08714729887836
• UDI-Public: 08714729887836
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Report Date (Section B): 10/13/2022

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: 01/17/2025
• Device Model Number: 2846
• Device Catalogue Number: 2846
• Device Lot Number: 0028703948
• 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: 07/04/2022
• Supplement Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2022
• 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; Other
• Patient Sex: Unknown