It was reported that three physicians have complained over the past 3-4 weeks that they have been having issues with the spring-wire guide.The md said that he advanced the guide wire through the introducer needle without an issue.As he advanced the wire through the vessel it would stick then not advance or withdraw.He said he knew he was in the vessel.It has happened to two other physicians.The rep.Discussed the insertion angle of the needle and dilator and stated that he's a very experienced inserter as the others.There was no reported delay, death, or complications to the patient as a result of this occurrence.
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Qn#(b)(4).Device evaluation: the report of difficulty advancing the guide wire was confirmed.Returned were a guide wire, an ars with a blue tip, an introducer needle, and a dilator.No defects or anomalies were observed on the ars, needle or dilator.The guide wire was kinked and bent at the distal end.The guide wire measured approximately 60.1 cm in length.The od of the guide wire measured 0.797, this met specification of 0.788 - 0.826 mm per guide wire graphic.A 0.032 inch od lab guide wire was inserted into the ars and introducer needle four times with the plunger in and then out, rotating the sample 1/4 turn each time.No resistance was experienced passing the guide wire through the ars and needle.The instruction booklet provided with the kit 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 review of the device history records did not reveal any manufacturing related issues.Based on the condition of the guide wire and the test results with the ars/needle assembly, operational context caused or contributed to this event.No further action will be taken.
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