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 ruby coils.During the procedure, the physician retracted the ruby coil because the coil was too large for the target location.However, while retracting within the lantern delivery microcatheter (lantern), the ruby coil unintentionally detached from its pusher assembly.Therefore, the physician used a syringe to create negative suction and removed the ruby coil.The procedure was then completed using new ruby coils and pod packing coils with the same lantern.There was no report of an adverse effect to the patient.
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