Qn#(b)(4).The customer did not return a complaint sample; however, they supplied a photo showing a kinked guide wire.A probable cause of the guide wire becoming kinked cannot be determined from the photo and without the sample to evaluate.A device history record review was performed with no evidence to suggest a manufacturing related cause.The ifu provided with this kit includes the following warnings and cautions for the user: "do not cut spring-wire guide to alter length." "do not withdraw spring-wire guide against needle bevel to minimize the risk of possible severing or damaging of spring-wire guide." "if resistance is encountered when attempting to remove the spring-wire guide after catheter placement, the spring-wire may be kinked about the tip of the catheter within the vessel." "although the incidence of spring-wire guide failure is extremely low , practitioner should be aware of the potential for breakage if undue force is applied to the wire"."do not apply excessive force in removing guide wire or catheters.If withdrawal cannot be easily accomplished, a chest x-ray should be obtained and further consultation requested".The report that the guide wire unraveled/separated was confirmed through examination of the customer supplied photo.The image showed the guide wire kinked; however, the actual complaint sample was not returned for evaluation.The device history records for the guide wire and catheter were reviewed with no evidence to suggest a manufacturing related cause.The probable cause of the guide wire damage could not be determined based upon the information provided and without the actual complaint sample returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.
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