It was reported the procedure was being performed in the nsicu.During insertion, the guide wire could not be removed smoothly.Upon removal it was found to be unraveled.As a result, a new kit was used successfully.There was a delay in treatment with no patient harm and no patient death or complications reported.
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Qn#(b)(4).Device evaluation: the report that the guide wire unraveled was confirmed.Returned were a guide wire and a guide wire advancer.No other components were received.The customer also provided photos of the sample.The guide wire was unraveled at the distal end.The core wire was separated adjacent to the weld at the distal end.Discoloration was observed at the broken end of the core wire, which is consistent with proximity to a weld.Microscopic inspection revealed a plastic deformation and necking of the wire in the area of the break.The distal weld was missing from the distal end of the coil wire.A manual tug test confirmed that the proximal weld is intact.The core wire measured approximately 60 cm in length.Based upon the measured length of the broken core wire, no pieces of the core wire appear to be missing.The od of the guide wire measured 0.795 mm.This met specification of 0.788 - 0.826 mm per the guide wire graphic.The instruction booklet provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage during use.It states that if resistance is encountered when attempting to remove the guide wire after catheter placement, the guide wire may be kinked about the tip of the catheter within the vessel.In this case it is recommended to withdraw the other remarks: catheter relative to the guide wire about 2-3 cm and then attempt to remove the guide wire.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.The device history records were reviewed with no relevant findings.The investigation found no evidence to suggest a manufacturing related cause.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Based on these circumstances, operational context caused or contributed to this event.No further action will be taken.
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