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Catalog Number RBY4C0315-B |
Device Problems
Break (1069); Premature Separation (4045)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/14/2022 |
Event Type
malfunction
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Event Description
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The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, while advancing the ruby coil through the lantern, the ruby coil unintentionally detached approximately midway in the lantern.The physician then removed the pusher assembly; however, the ruby coil remained in the lantern.Therefore, the lantern containing the detached ruby coil was removed and the coil was flushed out.Upon inspection, it was noticed that the proximal end near the detachment zone had become slightly separated.The procedure was completed using ruby coils and the same lantern.There was no report of an adverse effect to the patient.
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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.
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Manufacturer Narrative
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Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report:3005168196-2022-00463.
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Search Alerts/Recalls
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