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 gastroduodenal artery (gda) using a lantern delivery microcatheter (lantern), non-penumbra sheath, and ruby coils.During the procedure, while advancing a lantern through the sheath, the lantern got stuck within the sheath.Therefore, the lantern was removed.The procedure was completed a new lantern and the same sheath.There was no report of an adverse effect to the patient.
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