Qn#(b)(4).The actual device was not returned; however, the customer provided one photo of the product lidstock for analysis.The complaint of a kinked guide wire could not be confirmed by the photo.The photo shows the product lidstock and the device is not visible.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage." the customer report of a kinked guide wire could not be confirmed by visual inspection of the customer supplied photo.Additionally, full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, 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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