(b)(4).The customer returned an opened si-09880 kit which contained various components including a guide wire assembly.The guide wire was partially retracted into the advanced tube and the straightener tube was loose within the kit.The components showed evidence of use.The guide wire was observed to have several kinks towards the distal end of the body as well as at the center of the body.The distal j-bend was intact but kinked in several locations.Microscopic examination confirmed the kinks in the guide wire body.The core wire was visible through one of the kinks adjacent to the distal tip.Both welds were present and were observed to be full and spherical.The guide wire was kinked 20, 39, 201 and 428mm from the distal tip.The exposed core wire was observed at the kink 20mm from the distal tip.The overall length and outer diameter of the guide wire were measured and were found to be within specification.The guide wire was advanced through a lab inventory 18ga introducer needle to functionally test the guide wire.The guide wire passed through with minimal resistance.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record review was performed on the guide wire and no relevant manufacturing issues 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.The report that the guide wire kinked during use was confirmed through examination of the returned sample.The guide wire was kinked in several locations along the body.The returned guide wire met all relevant dimensional requirements and a device history record review 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.Teleflex will continue to monitor and trend for reports of this nature.
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