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Catalog Number RBY2C0825 |
Device Problems
Bent (1059); Detachment Of Device Component (1104); Device Handling Problem (3265)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/13/2017 |
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.This report is associated with mfr report numbers: 3005168196-2017-00357, 3005168196-2017-00358, 3005168196-2017-00359.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 hypogastric artery using ruby coils and lantern delivery microcatheters (lantern).It was noted that the patient had an abnormal hypogastric artery and it was difficult to gain access via the contralateral approach due to an acute turn at the arch of the iliacs.During the procedure, while retracting a ruby coil (lot #f72627) back into a lantern (lot #f70657) for repositioning, the physician experienced resistance and the ruby coil unintentionally detached from the pusher assembly inside the lantern around the acute angle area.Therefore, the lantern was removed with the detached coil inside.The physician then attempted to access from the contralateral side using a new lantern (lot #f72064).While a new ruby coil (lot #f60720) was being prepared on the back table for use, the ruby coil pusher assembly was bent and had unintentionally detached from its pusher assembly.Without knowing that, the physician advanced the ruby coil through the new lantern and into the patient but decided to retract the coil for repositioning.While attempting to retract the ruby coil, the physician noticed that the ruby coil had unintentionally detached from its pusher assembly.Therefore, the lantern was removed with the detached ruby coil.The procedure was then completed using an additional coil, which did not require a microcatheter.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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