Model Number FAS07070 |
Device Problem
Malposition of Device (2616)
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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 for this malfunction has not been returned to the manufacturer for evaluation; however, a medical image was received.The investigation of the reported malfunction is currently underway.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 fas07070 endovascular stent graft allegedly experienced malposition of device.This information was received from a single source.The malfunction involved a patient with no reported consequence.The patient¿s age, weight, and sex were not provided.
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Manufacturer Narrative
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H10: the lot number for the device was provided and a lot history review was performed.The device for this malfunction has not been returned to the manufacturer for evaluation; however, a medical image was received.The image review could not identify an issue with the stent.A definitive root cause could not be established.The device is labeled for single use.H10: g4 h11: h6 (results, conclusion) 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 fas07070 endovascular stent graft allegedly experienced malposition of device.This information was received from a single source.The malfunction involved a patient with no reported consequence.The patient¿s age, weight, and sex were not provided.
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Search Alerts/Recalls
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