Qn#(b)(4).The customer returned one spring wire guide (swg) inserted in a dilator and a lidstock for evaluation.Signs of use in the form of biological material were present on the dilator body.Visual inspection of the swg revealed it was kinked at the corresponding location of the dilator tip.The dilator had a deformed tip around the swg.The tip was warped and folded outward.The swg was removed from the dilator and an additional kink was identified.Microscopic examination confirmed the damaged dilator tip and that both welds on the swg were present and fully spherical.The kinks in the guide wire were located at 375 mm and 459 mm from the proximal weld.The total length of the swg measured 685 mm, which is within specifications of 679-687 mm per swg graphic.The guide wire outer diameter measured 0.798 mm, which is within specifications of 0.788-0.826 mm per swg graphic.The length of the dilator body measured 102 mm, which is within specifications of 95.2-108mm per dilator graphic.The outer diameter of the dilator body measured 2.853 mm which is within specifications of 2.81-2.87 mm per dilator graphic.The inner diameter of the dilator tip was not able to be measured accurately due to the deformation of the tip.The guide wire was passed through the distal tip of the dilator.Minor resistance was observed at the kinks; however, the guide wire was able to pass completely through the dilator.A manual a tug test confirmed that the proximal and distal welds were secure and intact.A device history record review was performed with no relevant findings.The instructions for use (ifu) provided with the kit warns the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".The customer report of a kinked swg was confirmed by complaint investigation of the returned sample.The dilator tip was found to be damaged which aligns with the device encountering undue force.The guide wire and the dilator met all relevant dimensional and functional testing, and a device history record review did not reveal any relevant findings.Based on the customer report and the sample received, unintentional user error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
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