Model Number FEM12060 |
Device Problems
Positioning Failure (1158); Material Perforation (2205)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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The lot number was provided for the reported malfunction; therefore, a lot history review is currently being performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.
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Event Description
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This report summarizes one malfunction.A review of the reported information indicated that model fem12060 endovascular stent graft allegedly experienced failure to deploy and material perforation.This information was received from one source.This event involved one patient with no patient consequences.Age, weight, and gender were not provided.
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Manufacturer Narrative
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H10: the lot number was provided for the reported malfunction and a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported malfunction was inconclusive.Based upon the available information, the definitive root cause for this malfunction was unknown.The device was labeled for single use.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Event Description
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This report summarizes one malfunction.A review of the reported information indicated that model fem12060 endovascular stent graft allegedly failure to deploy.This information was received from one source.This malfunction involved one patient with no patient consequences.Age, weight, and gender were not provided.
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Search Alerts/Recalls
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