Device code a0401 captures the reportable event of corewire break.The returned jagwire was analyzed.Upon visual assessment, it was observed that the distal tip was kinked as well as a small section was peeled exposing the core wire.Additionally, the core wire was fractured at the distal section.The broken section didn't return.Therefore, the complaint is confirmed for distal tip detached.Based on the condition of the returned device, engineers determined the things that occurred to the guidewire were most likely part of the device manipulation during the procedure, excess of force was applied to the device such as during the guidewire insertion through another device or the interaction with the scope, causing the damage on the distal end.Boston scientific has determined the most probable cause of this complaint is adverse event related to procedure.
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It was reported to boston scientific corporation that a jagwire was used during a pancreatic stone removal procedure performed on (b)(6) 2022.During the procedure, the 3-5 mm tip detached while seeking inside the pancreatic duct with a cannula and wire, the remains were found in fluoroscopic images and was safely removed from the pancreatic duct.The procedure was completed with a non-bsc device.There were no patient complications reported as a result of this event.
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