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: 3005168196-2021-01234.
|
The patient was undergoing a coil embolization procedure in the inferior mesenteric artery using a lantern delivery microcatheter (lantern) and a non-penumbra angiographic catheter.During the procedure, while advancing the lantern through the angiographic catheter, the lantern became stuck in the middle of the angiographic catheter.Subsequently, the physician retracted the lantern, flushed the angiographic catheter, and inspect the inside of the angiographic catheter by advancing a guidewire through it.However, when advancing the same lantern through the angiographic catheter, the same issue occurred.Therefore, the lantern was removed.The physician then advanced a new lantern through the same angiographic catheter against resistance to the target lesion and completed the procedure.There was no report of an adverse effect to the patient.
|