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: 3005168196-2017-00883.The hospital disposed of the device.
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The patient was undergoing a coil embolization procedure in the left subclavian artery (lsa) using ruby coils.During the procedure, the physician successfully deployed and detached five ruby coils in the lsa using a lantern delivery microcatheter.After placing the final ruby coil, the physician noticed that the last two ruby coils began to migrate within the patient¿s arm; therefore, the physician attempted to use a snare device to remove the ruby coils.However, the physician was unable to fully remove the ruby coils using the snare and, therefore did a cut on the patient arm and pulled out the ruby coils from the vessel and the procedure ended at this point.Post-procedure, the patient is doing fine.
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