(b)(4).The customer returned a single guide wire for evaluation.A visual exam was performed and it was observed that the guide wire had one significant kink at the center of the guide wire body and another slight kink towards the proximal end of the guide wire body.Microscopic examination confirmed both of the kinks.Both welds were present and were observed to be full and spherical.No damage was observed to the distal tip j-bend.The first significant kink was located 26.7cm from the proximal tip and the second slight kink was located 15.7cm from the proximal tip.The outside diameter (od) of the guide wire measured 0.817 mm, which met specification.The overall length of the guide wire was also found to be within specification.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, catheter, and insertion components, and no relevant findings were identified.The instructions-for-use (ifu) 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.Other remarks: the report that the guide wire kinked during use was confirmed through examination of the returned sample.The guide wire body was kinked in two locations; 26.7cm and 15.7cm from the proximal tip.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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