(b)(4).The customer did not return the actual sample; however, they did return a representative sample kit from lot#23f17b0357.No defects or anomalies were observed on the catheter or guide wire from the representative kit.The representative sample passed all relevant dimensional requirements.The guide wire was also advanced through the other insertion components with minimal resistance.All components functioned as expected.A manual tug test performed on the representative sample confirmed both the distal and proximal welds are intact.A device history record review was performed on the guide wire and catheter and no relevant findings were identified.Other remarks: the instructions-for-use (ifu) provided with this product describes suggested techniques to minimize the likelihood of guide wire damage during use.The ifu states that if resistance is encountered when attempting to remove the spring wire guide after catheter placement, the spring wire guide may be kinked about the tip of the catheter within the vessel.In this circumstance, withdraw the catheter relative to the spring wire guide about 2-3cm and attempt to remove the spring wire guide.If resistance is again encountered, remove the spring wire guide and catheter simultaneously.Complaint verification testing could not be performed as the actual complaint sample was not returned for analysis.A representative sample was returned and met all relevant visual, dimensional and functional requirements.A dhr review was performed and no relevant findings were identified.Without the actual complaint device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
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