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Catalog Number RBY2C2060 |
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 11/20/2017 |
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: 3005168196-2017-02271, 3005168196-2017-02272.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 type ii endoleak using ruby coils and pod packing coils (podjs).During the procedure, while attempting to advance two ruby coils and a podj through a lantern delivery microcatheter (lantern), the hospital technologist noticed a kink on the distal end of the coils pusher assemblies; therefore, the coils were removed.The hospital technologist believes the coils were inadvertently kinked while being removed from their dispenser hoops.The procedure was completed using additional ruby coils, podjs 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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