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 number: 3005168196-2018-01915.
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The patient was undergoing a coil embolization procedure in the internal iliac artery using pod6s and ruby coils.During the procedure, the nurse inadvertently kinked a pod6 while attempting to advance it into a lantern delivery microcatheter (lantern); therefore, the pod6 was removed.The physician then successfully deployed and detached a new pod6 in the target vessel.Next, the physician deployed and detached a ruby coil in the second branch of the target vessel with no issue.While attempting to advance a new ruby coil through the lantern, the ruby coil did not advance smoothly through the hub of the lantern; therefore, it was removed.Upon visual inspection, it was noticed that the ruby coil stretch resistant (sr) wire became stretched.The procedure was therefore completed using additional pod and ruby coils.There was no report of an adverse effect to the patient.
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