An arrowg+ard blue mac catheter was inadvertently placed into the junction of the right carotid artery and subclavian artery during attempted internal jugular vein cannulation.The resulting arterial injury required surgical repair and the pt subsequently suffered an embolic stroke, followed by death.Our subsequent simulation of the device insertion demonstrated that the dilator can puncture the posterior vessel wall, potentially damaging adjacent structures, when the guidewire is not inserted to sufficient depth.Under these conditions, the sharp tip of the dilator is not protected by protruding guidewire and can directly contact and penetrate the posterior vessel wall.Without sufficient wire to guide it, the dilator follows a straight trajectory from the skin surface, increasing the likelihood that it will penetrate the posterior vessel wall, rather than following the vessel lumen.The mfr does not provide instructions on appropriate guidewire insertion depth, the 45cm guidewire provided in the kit may contribute to the risk of this complication, a longer (60cm) guidewire is provided in a triple-lume catheter by the same mfr.The 45cm guidewire does not provide sufficient length within the target vessel if the operator allows greater than approx 10cm of guidewire external to the pt, to prevent the wire from embolizing into the pt.Including this case, we have observed 3 similar cases in the past year in our institution associated with this device, resulting in 3 arterial injuries, 2 strokes, one limb amputation, and one death.Fda safety report id# (b)(4).Ref # mw5093666, mw5093667.
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