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Model Number RBY2C0420-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 06/29/2021 |
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.(b)(4).Appropriate code not available to describe the problem of inability to use the ruby coil during the procedure.
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Event Description
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The patient was undergoing a coil embolization procedure using a ruby coil.During the procedure, the physician was unable to use a ruby coil; therefore, it was removed.No additional information regarding the specific issue with the ruby coil was provided.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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