(b)(4).The customer returned an introducer needle and a guide wire assembly for evaluation.The guide wire assembly consisted of a guide wire, advancer tube and straightener tube.The guide wire was returned partially retracted into the advancer tube with the exposed end advanced through the introducer needle.The components showed evidence of use.The customer reported resistance between the ars and guidewire; however, the returned guide wire was stuck within the introducer needle.Visual examination revealed the end of the guide wire beyond the needle bevel was kinked and distorted.The guide wire had several kinks towards the distal tip and at the juncture of the needle bevel.The kinking of the guide wire distorted the shape of the distal j-bend.No defects or anomalies were observed on the advancer tube or straightener tube.Microscopic examination revealed several offset coils along the curve of the guide wire j-bend and at the juncture of the needle bevel.The coils at the kinks were also observed to be slightly offset.Both welds were full and spherical.The kinks in the guide wire were located 0.8, 1.1 and 3.0cm from the distal tip.The offset coils were located between 0.8-1.1cm and 2.7-3.0cm from the distal tip.The guide wire and introducer needle met all relevant dimensional requirements.Other remarks: resistance was met while removing the guide wire from the needle; however, it was determined dried blood caused the resistance.Once the guide wire was removed and the needle cannula was cleaned, a lab inventory 0.025" guide wire was able to advance through the needle with minimal resistance.A manual tug test confirmed that both the proximal and distal welds were intact.A device history record (dhr) review was performed on the guide wire, introducer needle and ars and no relevant findings were identified.The instructions-for-use (ifu) provided with this 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.The customer reported resistance between the guide wire and ars; however, the returned guide wire was stuck within an introducer needle.The guide wire had several kinks and offset coils towards the distal tip and at the juncture of the needle bevel.Once the guide wire was removed and the needle cleaned of dried blood, the needle passed functional testing using a lab inventory guide wire of the same size (0.025").Both the guide wire and the introducer needle met all relevant dimensional requirements.A dhr review was performed and did not identify any manufacturing related issues.Based on the condition of the guide wire and the report that the damage was observed during use, it was determined that operational context caused or contributed to this event.
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