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Catalog Number RBY2C2457 |
Device Problems
Difficult to Advance (2920); Material Deformation (2976); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/10/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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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Event Description
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The patient was undergoing a coil embolization procedure to treat an endoleak using a ruby coil and a lantern delivery microcatheter (lantern).During the procedure, while advancing the ruby coil through the lantern, the physician kinked the pusher assembly of the ruby coil and experienced resistance in the lantern.Subsequently, the physician had difficulty advancing the ruby coil.Therefore, the ruby coil and the lantern were removed.Upon removal, the pusher assembly was pulled from the lantern and the ruby coil was found to be detached.The physician then flushed the microcatheter with saline and removed the detached coil from the lantern.The procedure was completed using a new ruby coil of the same size and the same lantern.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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