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Catalog Number RBY4C0860 |
Device Problem
Bent (1059)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/29/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The product was disposed of by the hospital and is no longer available for return.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 to treat a varicocele using ruby coils.During the procedure, the physician deployed and detached an initial ruby coil into the patient using a lantern delivery microcatheter (lantern).While the physician was advancing a new ruby coil into the lantern, the ruby coil pusher assembly became bent.Therefore, the ruby coil was removed and the procedure was successfully completed using a new ruby coil and the same lantern.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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