(b)(4).The customer returned a spring-wire guide (swg) for evaluation.Visual examination of the swg revealed three bends in the body.No other defects or anomalies were found.The j-bend tip was undamaged and the distal and proximal welds were intact, full, and spherical.The three bends in the swg were located approximately 16, 23, and 219 mm from the proximal weld.The length and outer diameter of the swg were measured and were found to be within specification.A device history review was performed and did not reveal any manufacturing related issues.The instructions for use provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage during use.It states that if resistance is encountered when attempting to remove the guide wire after catheter placement, the guide wire may be kinked about the tip of the catheter within the vessel.In this case it is recommended to withdraw the catheter relative to the guide wire about 2-3 cm and then attempt to remove the guide wire.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 reported complaint of guide wire kinking was confirmed by complaint investigation.The guide wire contained three bends.A device history record review was performed with no relevant findings.Based on the sample received, it was determined that operational context caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
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