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Catalog Number RBYPOD6 |
Device Problems
Kinked (1339); Failure to Advance (2524); Device Handling Problem (3265)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/08/2018 |
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.The hospital disposed of the device.
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Event Description
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The patient was undergoing a coil embolization procedure in the splenic artery using pod6s.During the procedure, while attempting to advance a pod6 into a non-penumbra microcatheter, the hospital technologist inadvertently kinked the pod6 pusher assembly.It was reported that the physician still attempted to advance the pod6 through the microcatheter but the pod6 would not advance; therefore, the microcatheter and pod6 were removed.The procedure was completed using a new microcatheter and another pod6.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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