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Catalog Number RBYPODJ60 |
Device Problems
Material Deformation (2976); Premature Separation (4045)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/29/2022 |
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 using a pod packing coil (pod pc) and a lantern delivery microcatheter (lantern).During the procedure, the physician advanced the lantern into the patient and then advanced the pod pc into the lantern.While advancing the pod pc into the target location, the physician bent the pusher assembly of the pod pc and the coil unintentionally detached within in the microcatheter.Therefore, the lantern and pod pc were removed together and flushed.The procedure was completed using new coils 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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