Qn#(b)(4).Associated mdr#s: 9680794-2023-00797.The customer report of an unravelled guide wire was confirmed by visual inspection of the customer supplied photos.The photos show a used guidewire that is kinked in several locations and appears unraveled, however, no conclusions about the cause of the damage can be made from the photos alone.A complete visual inspection could not be performed as no sample was returned for analysis.The instructions for use (ifu) provided with this kit warns the user, "warning: 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." 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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