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Model Number FEM12060 |
Device Problems
Positioning Failure (1158); Material Perforation (2205); Material Twisted/Bent (2981)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/30/2018 |
Event Type
malfunction
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Manufacturer Narrative
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As the lot number for the device was provided, a manufacturing review will be 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 instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.The information provided by bard 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 bard.
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Event Description
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It was reported that the stent graft tip was allegedly bent.There was no reported patient injury.
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Event Description
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It was reported that the stent graft tip was allegedly bent perforating the system outer sheath.There was no reported patient injury.
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Manufacturer Narrative
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Manufacturing review: based on the information available and the investigation performed, there is no indication that the product failed to meet its specification prior to shipment.The lot records have been reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.The review shows that no remarkable incidents occurred during the manufacturing process.No relevant manufacturing process changes were implemented, that could have led to the event reported.Investigation summary: on the basis of the provided images and the information available the alleged strut perforation could be confirmed.The distal catheter tip was found to be perforated by a stent graft strut which made a stent graft deployment impossible.No indication for a manufacturing related issue could be identified.Based on the information available and the evaluation of the images, a definite root cause for the reported event could not be determined.Labeling review: in reviewing the labeling supplied with this product it was found that the instructions for use (ifu) sufficiently address the potential risk.The ifu states: "if unusual resistance or high deployment force is encountered during stent graft deployment, abort the procedure, remove the delivery system and use an alternative device." regarding the use of accessories the ifu states: "materials required for the fluency® plus endovascular stent graft procedure: (.) introducer sheath with appropriate inner diameter (.)".Furthermore, the ifu states: "prior to loading the endovascular system over a guide wire, both ports must be flushed with sterile saline (¿).Flushing these lumens will also facilitate stent graft deployment.".
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Search Alerts/Recalls
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