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Model Number RBYPOD4-A |
Device Problems
Break (1069); Retraction Problem (1536); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/13/2021 |
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 right internal mammary artery (rima) using pod coils and a non-penumbra microcatheter.During the procedure, a pod coil was advanced into the microcatheter and became stuck midway.The hospital technologist attempted to pull the pod coil back into the introducer sheath, but the pod coil was unable to completely retract out of the microcatheter.The physician then removed the introducer sheath to find the pod coil stuck in the microcatheter, hanging halfway out and detached from the pusher assembly.Therefore, the physician pulled the detached pod coil out of the microcatheter by hand.It was reported the microcatheter may not have been flushed prior to introducing the pod coil.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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