The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, the physician met resistance while advancing a ruby coil.Upon retraction, the ruby coil unintentionally detached within the microcatheter.The microcatheter was removed with the detached ruby coil inside.The physician had difficulty positioning a new ruby coil and it unintentionally detached.A snare device was required to successfully remove the detached ruby coil from the body.There was no report of an adverse effect on the patient.
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Conclusion: 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 mdr is associated with mdr 3005168196-2014-00854.The hospital discarded the device.
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