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: 3005168196-2020-01362.
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The patient was undergoing a coil embolization procedure in the right gastric artery using ruby coil lps and a non-penumbra microcatheter.During the procedure, while advancing a ruby coil lp in the introducer sheath, the pusher assembly of the ruby coil lp bent and broke.Subsequently, the ruby coil lp was removed.The physician continued with the procedure using another ruby coil lp, but the same issue occurred.Therefore, the second ruby coil was removed.The procedure was completed using another penumbra lp coil and the same microcatheter.There was no report of an adverse effect to the patient.
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