(b)(4).Device evaluation: it was reported that it was then difficult to thread the catheter over the wire was confirmed.The customer returned a guide wire and three pictures.No catheter was returned.The pictures showed the lidstock and part of guide wire with one kink visible.Visual examination of the returned sample revealed one kink in the middle of the wire and the j- bend was partly opened.A manual tug test confirmed both welds are intact.Microscopic examination confirmed the kink and confirmed that both welds were full and spherical.No separations or offset coils were observed.The kink was measured at 26.3 cm from the distal weld.The guide wire measured 60.1 cm, which meets the length specifications of 59.6 - 60.4 cm per the guide wire graphic.The diameter (od) of the guide wire measured 0.803 mm, which is also within the od specification of 0.788 - 0.826 mm per the guide wire graphic.The instructions for use describes suggested techniques to minimize the likelihood of guide wire damage during use.The instructions caution that withdrawing the guide wire against the needle bevel or use of excessive force during removal could damage or break the wire.A device history record review was performed and found no evidence to indicate other remarks: a manufacturing related cause.The probable cause of the guide wire kinking with catheter resistance during insertion could not be determined based upon the information provided and without a complete sample.No further action will be taken.
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