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: 3005168196-2019-01113.
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The patient was undergoing a coil embolization procedure in the renal artery using ruby coils and pod14s.During the procedure, the pusher assembly of a ruby coil became kinked while being removed from the packaging hoop.The damage to the ruby coil occurred prior to use and, therefore, it was not used in the procedure.The physician then felt resistance while advancing the pod14 into the lantern delivery microcatheter (lantern) and, consequently, the pod14 unintentionally detached.The physician was able to pull out the pod14, and the procedure was then completed using a pod12 and the same lantern.There was no report of an adverse effect to the patient.
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