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: 3005168196-2018-02040.
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The patient was undergoing a coil embolization procedure in the left hypogastric artery using pod4s and a lantern delivery microcatheter (lantern).During the procedure, the physician had difficulty while attempting to advance a pod4 through a lantern.It was reported that the pod4 became stuck in the lantern and therefore, both lantern and pod4 were removed.The procedure was completed using a new pod coil and a new lantern.There was no report of an adverse effect to the patient.
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