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Model Number RBY4C0204-B |
Device Problems
Failure to Advance (2524); Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/06/2021 |
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.
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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, the physician experienced resistance and the ruby coil would not advance past the hub of the microcatheter.Subsequently, the pusher assembly of the ruby coil became bent.Therefore, the ruby coil was removed.The procedure was completed using additional ruby coils 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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