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Catalog Number RBY2C2457 |
Device Problem
Deformation Due to Compressive Stress (2889)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/15/2018 |
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 using ruby coils.During the procedure, the physician inadvertently kinked a ruby coil pusher assembly while attempting to advance it through a lantern delivery microcatheter (lantern); therefore, it was removed.The procedure was completed using three additional ruby coils 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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