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 lantern delivery microcatheter (lantern), non-penumbra coils, a non-penumbra catheter, and a guidewire.During the procedure, the physician placed a non-penumbra coil into the target vessel using the microcatheter.While advancing the next non-penumbra coil through the middle of the lantern, the physician experienced resistance.Therefore, the non-penumbra coil and lantern were removed together.The procedure was completed using a pod packing coil (pod pc), another microcatheter, the same catheter and the same guidewire.There was no report of an adverse effect to the patient.
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