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Model Number RBYPOD12-A |
Device Problem
Failure to Fold (1255)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/29/2021 |
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.
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Event Description
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The patient was undergoing a coil embolization procedure in the ovarian vein using pod coils and a non-penumbra microcatheter.During the procedure, the pod coil would not anchor and kept running down the vessel.Therefore, the pod coil was removed.The procedure was completed using a new pod coil 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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