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 distal arteriovenous fistula (avf) using penumbra smart coils (smart coil), a penumbra smart coil detachment handle (handle), and a non-penumbra microcatheter.During the procedure, the physician placed and detached two smart coils in the target vessel using the handle.The physician advanced the next smart coil into the target vessel and made two attempts to detach it using a handle; however, the smart coil failed to detach.Therefore, the physician used a hemostat to manually detach the smart coil.Next, the physician advanced a fourth smart coil into the vessel and the same issue occurred.Therefore, the physician attempted to detach the smart coil using a hemostat, but the coil would not detach, and the physician decided to remove the smart coil.However, while retracting, the smart coil unintentionally detached inside the microcatheter.It was reported that the physician opened a fifth smart coil to use the pusher assembly and push the previous detach smart coil that was inside the microcatheter back into the target location.The procedure was completed using an embolic agent.There was no report of an adverse effect to the patient.
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