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Catalog Number RBYPOD6 |
Device Problems
Failure to Fold (1255); Difficult To Position (1467)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/25/2018 |
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, the pod6 was unable to form in the vessel, despite the vessel measuring 6mm.The pod6 was therefore removed, and the procedure was completed using pod5s and ruby coils.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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