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 in the inferior mesenteric artery (ima) using a ruby coil, a ruby coil detachment handle (handle), a non-penumbra microcatheter, a 5fr non-penumbra sheath, a 5fr non-penumbra guide catheter, and a non-penumbra guidewire.It was noted that the patient¿s anatomy was extremely tortuous.During the procedure, the physician advanced the sheath into the right groin, advanced the guide catheter through the sheath, and advanced the microcatheter to the target vessel through the guide catheter.The physician then flushed the ruby coil and microcatheter with saline on the back table.While re-attempting to advance the ruby coil to the target vessel using the microcatheter, the ruby coil became stuck and would not exit the microcatheter.The physician then removed the ruby coil and flushed the microcatheter again with saline.While attempting to re-advance the ruby coil, the same issue occurred.Therefore, the ruby coil was removed.The procedure was completed using a non-penumbra coil and the same microcatheter.There was no report of an adverse effect to the patient.
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