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Catalog Number RBY4C0305 |
Device Problems
Defective Device (2588); Insufficient Information (3190)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/31/2018 |
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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During preparation for a coil embolization procedure, the hospital staff noticed the ruby coil was not usable upon removal from the packaging hoop.The ruby coil, therefore, was not used in procedure, and the procedure was completed using a ruby coil.
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Search Alerts/Recalls
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