Boston Scientific—HABIB EUS Radio-Frequency Ablation Catheters: May Transfer Energy to the Introducer, Potentially Causing Thermal Tissue Injury
December 4, 2019 | Risk Management News
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In a November 18, 2019, Urgent Field Safety Notice letter posted by the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA), Boston Scientific (BSC) states that the above devices may transfer energy from the active tip to the introducer device, potentially causing thermal injury to tissue outside the intended treatment area. BSC also states that the most common injury anticipated should require little or no intervention; however, the possibility of tissue damage or perforation requiring medical intervention is remote. BSC further states that it has received no...