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Catalog Number RBY2C2457-B |
Device Problems
Device Damaged Prior to Use (2284); Deformation Due to Compressive Stress (2889)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/24/2018 |
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 that a ruby coil became kinked upon removal from the packaging hoop on the back table.The damage to the ruby coil was found prior to use and, therefore, it was not used in the procedure.The procedure was completed using a new ruby coil.
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Search Alerts/Recalls
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