Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this ekosonic endovascular device was visually inspected.It was found that the ultrasonic core (usc) was fractured in two pieces at approximately 102cm from the luer barb.The detached piece of the usc was not returned.The infusion catheter (ic) had small pinches at 61, 84, and 96cm from the strain relief.A ring gauge of was passed over the ic to confirm the outer diameter and had difficulty passing over multiple spots that coincided with the pinches noticed between 60-100cm from the ic strain relief.A guidewire was then inserted into the bend jig, and the ic was advanced over the guidewire.The ic met significant resistance when inserted into the tip of the ic, approximately 96cm from the strain relief, and was unable to be advanced.The usc was inserted into the distal end of the ic and met resistance approximately 66cm from the strain relief of the ic.It was not possible to advance the usc or the guidewire through the section that was 66-94cm from the strain relief.Dye was injected into the central lumen to help visualize changes to the diameter of the central lumen.It was noticed that the pinches at 63cm and 96cm from the strain relief were significant enough to prevent the advancement of the ic over the guidewire.The reported event of difficulty advancing the catheter over the guidewire was confirmed.
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