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.
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The patient was undergoing a coil embolization procedure in the superior mesenteric artery (sma) using ruby coils, a lantern delivery microcatheter (lantern) and a non-penumbra catheter.During the procedure, while advancing a lantern through the catheter, the physician experienced resistance; therefore, the lantern was removed.The procedure was completed using ruby coils, a non-penumbra microcatheter and the same catheter.There was no report of an adverse effect to the patient.
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