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: 3005168196-2017-00978.
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The patient was undergoing coil embolization procedure in the gastroduodenal artery (gda) using ruby coils.During the procedure, the physician successfully deployed and detached initial ruby coils into the target vessel using a non-penumbra microcatheter.While advancing a new ruby coil through the microcatheter, the physician did not mention any resistance; however, the coil unintentionally detached while partially inside the vessel.Therefore, the physician used a snare device to remove the detached ruby coil.Next, while attempting to advance a new ruby coil through the microcatheter, the physician did not mention any resistance; however, the coil was unable to completely advance out of the tip of the microcatheter.Therefore, the ruby coil was removed and it was noted that the pusher assembly appeared to be bent.The procedure was then successfully completed using additional coils and a lantern delivery microcatheter (lantern).There was no report of an adverse effect to the patient.
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