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Catalog Number RBY2C0620 |
Device Problems
Deformation Due to Compressive Stress (2889); Inadequate User Interface (2958)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/01/2018 |
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.This report is associated with mfr report number: 3005168196-2018-01477.
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Event Description
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The patient was undergoing a coil embolization procedure in the splenic artery using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, while attempting to advance a ruby coil into a lantern, the hospital technologist kinked the ruby coil pusher assembly; therefore, it was removed.Upon removing the ruby coil, the hospital technologist inadvertently kinked the lantern that was being used.The procedure was completed using a new lantern and three additional ruby coils.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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