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 splenic artery using a pod packing coil (pod pc), ruby coils, and a non-penumbra microcatheter.It should be noted that the patient¿s anatomy was severely tortuous.During the procedure, the physician successfully implanted ten ruby coils using the microcatheter.Subsequently, the physician experienced resistance while advancing a pod pc through the microcatheter.The physician continued to advance the pod pc, and consequently, the pod pc pusher assembly broke with a few centimeters of the pod pc outside of the distal end of the microcatheter.It was reported that the pod pc was stuck.Therefore, the physician applied negative pressure using a syringe and removed the microcatheter with the pod pc inside.The pod pc was then pulled out of the microcatheter by hand.Next, the physician flushed the microcatheter and reinserted it into the patient.The procedure was completed using a new pod pc, 13 coils, and the same microcatheter.There was no report of an adverse effect to the patient.
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