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 numbers: 3005168196-2019-01907.3005168196-2019-01908.
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The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, while attempting to advance a ruby coil through a lantern delivery microcatheter (lantern), the ruby coil detached partially in the introducer sheath and partially into the lantern; therefore, the hospital technologist pulled the ruby coil out from the lantern.The hospital technologist then attempted to advance another two ruby coils; however, they detached partially in the introducer sheath and partially into the lantern.Therefore, the hospital technologist pulled the two ruby coils out from the lantern.The procedure was completed using other ruby coils and the same lantern.There was no report of an adverse effect to the patient.
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