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Catalog Number RBYPOD3 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/19/2018 |
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.This report is associated with mfr report number: 3005168196-2018-01619.
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Event Description
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The patient was undergoing a coil embolization procedure using a pod3 and pod4.It was noted that this was an extremely high flow environment.During the procedure, the physician was unable to get the pod4 and pod3 to anchor.It was reported that the physician made multiple attempts but the coils kept running; therefore, they were removed.The procedure was completed using two ruby coils, a pod packing coil.There was no report of adverse effect to the patient.
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Search Alerts/Recalls
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