Qn# (b)(4).The actual device was not returned; however, the customer provided two photos for analysis.The complaint of a kinked guide wire was able to be confirmed by the photo.The product lidstock was also pictured.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." without the device to evaluate, the probable cause could not be determined from the available information.Teleflex willcontinue to monitor and trend for reports of this nature.
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