The user facility reported that a neuro procedure, diagnostic cerebral, was performed via a glide-sheath slender.The physician had radial access and advanced the wire within the needle which comes in the kit.The physician tried to withdraw the needle and part of wire came out with the needle.The brite nitinol tip of the wire stayed inside the arm.The physician abandoned radial access and used cook micro puncture set via femoral.The patient had retained foreign body which resulted in surgery cut down to remove fbv.The patient condition and procedure outcome are unknown.Additional information received on (b)(6) 2021: wire was successfully removed during surgery.
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This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.A review of the device history record of the product code/lot# combination was conducted with no findings.One 5fr glidesheath slender guidewire was returned for product evaluation.The returned guidewire was subject to visual analysis, and it was observed that the guidewire was broken and contained a region of open coil near the broken end.The portion of the guidewire that was retained in the patient was not returned, but the site contact confirmed that it was successfully removed from the patient.Dimensional testing was performed.The returned guidewire was measured to be 41cm long.The guidewire length specification is 42.8cm to 44cm.The only region of coil on the guidewire was from 3.3cm to 3.9cm from the separated end of the guidewire and appeared to be deformed.This is consistent with where the epoxy region of the guidewire should be according to the manufacturer's specifications.From 3.3cm to the separated end of the guidewire, the coil was open.The diameter of the proximal shaft of the guidewire was measured to be 0.206in.The specification of the part is 0.205in to 0.210in.The diameter of the distal end of the guidewire was not measured due to the state of the sample.The complaint can be confirmed for guidewire mechanical separation as the sample was broken near the floppy end it's short length.The exact root cause could not be determined.The device was in a conforming state when released from terumo control.There is no indication that any manufacturing issues may have led to this event.Currently no action is recommended since this risk evaluation is within the predetermined limits in the fmea.
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