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Catalog Number RBYPOD6 |
Device Problem
Difficult to Fold, Unfold or Collapse (1254)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/23/2015 |
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: 3005168196-2015-01183.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 pod6 coils.During the procedure, the physician was unable to advance a pod6 coil out of the orange introducer sheath and pod6 coil was removed.The physician then attempted to deploy a new pod6 coil into splenic artery; however, the pod6 coil did not coil up properly in the vessel and was removed from the patient.The procedure was completed using a new ruby coil.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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