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Model Number RBY2C2457-A |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/16/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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 using a ruby coil and a lantern delivery microcatheter (lantern).During the procedure, it was reported that a ruby coil could not be implanted.Therefore, the ruby coil was removed.No additional information regarding the completion of the procedure was provided.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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