Philips—Visions PV .035 Intravascular Ultrasound Catheters: Guidewire May Be Unable to Pass through Catheter's Y-Port
October 24, 2018 | Risk Management News
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In an October 13, 2018, Medical Device Advisory Notice letter submitted by an ECRI Institute member hospital, Philips states that the guidewire of may not be able to pass through the above catheter's Y-port. Philips further states that it has received reports that approximately 20% of devices in affected lots may exhibit this problem. Philips also states that while it has not received reports of adverse events caused by this problem, patient treatment may be delayed while clinical staff exchange affected catheters for another device. The manufacturer has not confirmed the...