It was reported that during insertion in the rcw, resistance was met when inserting the guide wire resulting in the kinking of the wire.As a result, a new kit was opened and used without issue.A delay was reported, however, there was no additional harm to the patient due to this delay or as a result of this occurrence.
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Qn#(b)(4).Device evaluation: the report that the guide wire kinked during insertion was confirmed.Returned by the customer was one guide wire with additional components that included the arrow raulerson syringe/introducer needle assembly.A visual examination of the guide wire revealed a partially opened j-tip.A manual tug test confirmed that both welds remain intact.The wire measured 602 mm in length and the outside diameter (od) measure.800 mm.The returned guide wire was within specification for length and od per guide wire graphic (length: 596 - 604 mm and od: 0.788- 0.826 mm).Microscopic examination of the guide wire revealed a slight bend at 6.5 cm from the distal tip.Visual inspection of the ars/needle assembly was performed and both appeared typical but used.A functional test was performed in an attempt to verify the complaint using the returned guide wire, the ars, and needle.The guide wire was inserted into the ars and needle four times each at a different orientation by rotating the syringe 1/4 turns at each insertion and with the plunger in and out.The guide wire passed through each time and no resistance was met.The instructions for use describe suggested techniques to minimize the likelihood of guide wire damage during use.A device history records review was performed other remarks: with no evidence to suggest a manufacturing related issue.Based on these circumstances, operational context caused or contributed to the event.No further action will be taken.
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