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Model Number RBY4C0406-B |
Device Problems
Break (1069); Physical Resistance/Sticking (4012); Premature Separation (4045)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/19/2021 |
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 to treat a gastrointestinal (gi) bleed using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician encountered resistance while advancing the ruby coil through the lantern and subsequently, the coil became detached.The physician observed under fluoroscopy visualization that there was a gap or break in the ruby coil and therefore, the lantern containing the detached ruby coil was removed from the patient.The ruby coil was then removed from the lantern and appeared to be broken into two pieces.The procedure was completed using another ruby coil 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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