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Catalog Number RH1 |
Device Problems
Mechanical Problem (1384); Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/24/2017 |
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 product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report number: 3005168196-2017-02265.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 gastrointestinal (gi) bleed using ruby coils and a ruby coil detachment handle (handle).During the procedure, the physician successfully deployed and detached initial ruby coils into the patient using a non-penumbra microcatheter and the handle.The physician was then unable to detach a new ruby coil using the same handle.Therefore, the ruby coil was removed and the procedure was completed using a new ruby coil, the same handle 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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