Product event summary: the full guidewire was returned in segments and analyzed.The analysis indicated that the guidewire was kinked/buckled.The guidewire was broken.The guidewire was unraveled.Visual analysis of the lead indicated damage during use.The analyst noted that the proximal portion of the guidewire was received in dispenser, and the distal portion was broke and stuck in lead.Visual inspection found the guidewire tip was kinked inside the lead tip nose.The visual inspection result leads us to conclude that during the procedure the guidewire was kinked.Kinked wire was obstructed by the lead conductor, and could not remove the guidewire from lead.The guidewire broke possible when force was applied.If information is provided in the future, a supplemental report will be issued.
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