The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report numbers: 3005168196-2017-01564, 3005168196-2017-01565.The hospital discarded the device.
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The patient was undergoing a coil embolization procedure to treat a renal arteriovenous malformation (avm) using ruby coils.It was noted that the patient had a very tortuous anatomy.During the procedure, while attempting to advance a ruby coil through a lantern delivery microcatheter (lantern), the physician experienced stiffness and subsequently, the ruby coil unintentionally detached within the lantern.Therefore, the physician removed the lantern containing the detached coil, then flushed the coil out and reinserted the lantern into the patient's body.While attempting to advance a new ruby coil through the lantern, the physician experienced stiffness again and subsequently, the ruby coil unintentionally detached within the lantern.Therefore, the physician removed the lantern containing the detached coil and flushed the coil out.The physician then discovered that the lantern was kinked.Therefore, the lantern was set aside and the procedure was completed using a new lantern and three additional ruby coils with no problem.There was no report of an adverse effect to the patient.
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