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: 3005168196-2021-00757.
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The patient was undergoing a coil embolization procedure in the abdominal aortic aneurysm (aaa) sac using pod packing coils (pod pcs), a lantern delivery microcatheter (lantern), and non-penumbra diagnostic catheter.During the procedure, the physician placed two pod pcs in the target location.Subsequently, the next pod pc became stuck inside the lantern after advancing to a certain point and would not retract.It was reported the physician had advanced the diagnostic catheter without a wire and had manipulated the lantern without a wire.When attempting to pull the pod pc back, the pod pc unintentionally detached in the lantern.Therefore, the detached pod pc and lantern were removed together.The lantern was inspected, and the hospital staff noticed the lantern was kinked at the distal shaft, around the area where the pod pc was getting stuck.The procedure was completed using two new pod pcs and a new lantern.There was no report of an adverse effect to the patient.
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