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Model Number RBY4C0406-B |
Device Problems
Physical Resistance/Sticking (4012); Premature Separation (4045)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/04/2020 |
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 ovarian vein using ruby coils and non-penumbra microcatheter.During the procedure, the physician placed ruby coils in the target location using the microcatheter.While attempting to place another ruby coil, the physician experienced resistance after advancing the ruby coil halfway through the microcatheter.Consequently, the ruby coil had unintentionally detached within the microcatheter.Therefore, the microcatheter containing the detached ruby coil was removed and the coil was flushed out.The procedure was completed using additional ruby coils and the same microcatheter.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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