Model Number FEM12040 |
Device Problems
Positioning Failure (1158); Material Perforation (2205); Misfire (2532); Material Deformation (2976)
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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 device was returned for the one malfunction.The company is still investigating the issue at this time.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 fem12040 endovascular stent graft allegedly experienced failure to deploy, material perforation and deformation.This information was received from one source.The event involved a patient with no known impact to the patient.The patient 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 completed.The device was returned for the one malfunction and the evaluation confirmed for positioning failure, misfire, and material perforation.A root cause was not determined.The device is 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: fem12040 endovascular stent graft allegedly experienced positioning failure, material perforation and misfire.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The patient age, weight, and gender were not provided.
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Search Alerts/Recalls
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