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Catalog Number RBY2C1035 |
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 12/21/2017 |
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: 3005168196-2018-00158, 3005168196-2018-00160.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 left hypogastric artery using ruby coils and pod packing coils (podjs).During the procedure, the physician deployed and detached a ruby coil in the target vessel using a lantern delivery microcatheter (lantern).While attempting to advance two other ruby coils through the lantern, the hospital technologists inadvertently kinked the coils pusher assemblies; therefore, they were removed.The procedure continued by placing a new ruby coil in the target vessel.While attempting to advance a podj through the lantern, the hospital technologist inadvertently pulled the lantern out of the vessel which caused the coil to unintentionally detach inside the lantern.Therefore, the lantern containing the detached coil was removed and the coil flushed out.The procedure was completed using another podj 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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