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 right internal iliac artery (iia) using a lantern delivery microcatheter (lantern) and ruby coils.It was noted that the patient anatomy was tortuous.During the procedure, the physician placed two ruby coils in the left iia using the lantern.Afterwards, the physician placed the lantern in the right iia.After advancing the next ruby coil approximately ten centimeter through the distal tip of the lantern, the ruby coil became stuck.Subsequently, the physician decided to retract the ruby coil.Upon retraction, the ruby coil unintentionally detached inside the lantern.Therefore, the lantern containing the detached ruby coil was removed.The procedure was completed using another ruby coil, two pod packing coils (pod pcs) and the same lantern.There was no report of an adverse effect to the patient.
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