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Catalog Number RBYPODJ45 |
Device Problems
Kinked (1339); Device Handling Problem (3265)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/01/2017 |
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: 3005168196-2017-02326.The hospital disposed of the device.
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Event Description
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During preparation for a coil embolization procedure, the radiologic technologist severely kinked a ruby coil and a pod packing coil (podj) pusher assemblies while attempting to load them into a lantern delivery microcatheter (lantern) on the back table.The ruby coil and podj pusher assemblies became damaged prior to use and therefore, the ruby coil and podj were not used in the procedure.The procedure was completed using a new ruby coil, podj and the same lantern.
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Search Alerts/Recalls
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