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Catalog Number RBY4C0202 |
Device Problems
Kinked (1339); Device Handling Problem (3265)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/07/2018 |
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.The hospital disposed of the device.
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Event Description
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The patient was undergoing a coil embolization procedure in the right gastric artery using ruby coils.During the procedure, while attempting to advance a ruby coil through a non-penumbra microcatheter, the hospital technologist inadvertently kinked a ruby coil pusher assembly; therefore, it was removed.The procedure was completed using another ruby coil and the same microcatheter.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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