Biosense Webster—MobiCath Bi-Directional Guiding Sheaths: Inner Lumen Anomalies May Lead to Patient Embolic Event

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In a November 12, 2012, Urgent Field Safety Notice letter submitted by an ECRI Institute member hospital, Biosense Webster states that Greatbatch reported some anomalies of the inner lumen of the sheaths below, including loose, string-like liner material, liner abrasion (fraying), and/or attached string-like liner material (from scratches or damage on the inner wall of the sheath lumen). Biosense Webster states that it has received no reports of adverse events resulting from this problem; however, a loose piece of the liner could be introduced into a patient during a procedure, potentially resulting in an embolic event. The manufacturer and distributor have not confirmed...