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Catalog Number RBY2C0320 |
Device Problems
Bent (1059); Material Deformation (2976); Device Handling Problem (3265)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/05/2017 |
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.The hospital disposed of the device.
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Event Description
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The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, while attempting to load a ruby coil into the microcatheter, the scrub technologist did not mention any resistance but pushed too hard and inadvertently bent the ruby coil pusher assembly.The pusher assembly was severely damaged near the friction lock.Therefore, the ruby coil was removed and the procedure was completed using two additional ruby coils and the same microcatheter without further issues.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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