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: 3005168196-2017-00418, 3005168196-2017-00419, 3005168196-2017-00420, 3005168196-2017-00457.The hospital disposed of the device.
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The patient was undergoing a coil embolization in the external and internal iliac artery using ruby coils and pod packing coils (podj coils).During the procedure, the physician advanced two ruby coils in the target vessel using a lantern delivery microcatheter (lantern); however, due to a very high flow in the internal iliac artery, both ruby coils would not take their intended shape and anchor in the aneurysm.After several failed attempts, the ruby coils were removed and a pod8 coil was successfully deployed and detached in the aneurysm.The scrub technologist then inadvertently bent both ruby coils pusher assemblies while attempting to re-sheath them.Next, the scrub technologist inadvertently pulled off the introducer sheath of podj coil after removing it from the packaging hoop.While attempting to re-sheath it, the podj coil pusher assembly was accidentally broken; therefore, the podj coil was set aside.The physician then opened a new podj coil and attempted to advance it through the lantern; however, resistance was experienced prior to the coil exiting the lantern and the physician decided to retract it.Upon retraction, the podj coil unintentionally detached from the pusher assembly and unraveled inside the lantern.The lantern was then pulled out of the other manufacturer¿s 5f catheter with the detached coil still inside.It was reported that the technician dropped the first lantern; therefore, it was not used for the remainder of the procedure.The procedure was completed using another lantern and additional ruby coils.In addition, there was no alleged deficiency with the first lantern.There was no report of an adverse effect to the patient.
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