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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 05/31/2018 |
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.This report is associated with mfr report numbers: 3005168196-2018-01285, 3005168196-2018-01286, 3005168196-2018-01287, 3005168196-2018-01288.The hospital discarded the device.
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Event Description
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The patient was undergoing a coil embolization procedure in the aorta using ruby coils and a ruby coil detachment handle (handle).It was noted that the patient's anatomy was tortuous.During the procedure, the physician advanced a ruby coil into the target vessel using a lantern delivery microcatheter (lantern) and used a handle to detach it; however, the ruby coil failed to detach.Therefore, the physician manually detached the ruby coil.It was reported the same issue occurred with two additional ruby coils.While attempting to advance a new ruby coil through the lantern, the physician experienced resistance and the ruby coil would not advance; therefore, it was removed.The procedure was completed using another ruby coil, a second handle 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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