Catalog Number FEM08100 |
Device Problems
Material Invagination (1336); Failure to Advance (2524); Detachment of Device or Device Component (2907)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/08/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The device history records are being reviewed.The event is currently under investigation.
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Event Description
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It was reported that during the attempt to load the stent delivery system onto a 0.035" guide wire prior to the procedure, the outer tip of the delivery system became detached.Reportedly, the blue portion of the catheter was noticeable.Another stent graft was used with the same guide wire to perform the procedure.There was no patient involvement.
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Manufacturer Narrative
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The lot history records have been reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met all specifications prior to shipment.There is no indication for a manufacturing-related failure.The evaluation of the returned device revealed that the deployment mechanism had not been used and that both the inner and outer catheter tip were invaginated in the tip section.The reported detachment could not be confirmed.Potential factors that may have caused or contributed to the reported event have been evaluated.As the reported event was found to be an isolated incident, no investigations of similar complaints could have been reviewed.During the evaluation, the tip section of the delivery system was found to be invaginated.This type of event may be associated with the use of an inappropriate guide wire or insufficient flushing of the device.Rough handling of the device during unpacking or preparation also may contribute to this type of event.On the basis of the information available and the evaluation of the returned device, a definite root cause for the reported event could not be determined.The ifu states that the device must be flushed with sterile saline.Furthermore, 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." also the ifu indicates that a 0.035" guide wire is required for the procedure.
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Event Description
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It was reported that during the attempt to load the stent delivery system onto a 0.035" guide wire prior to the procedure, the outer tip of the delivery system became detached.Reportedly, the blue portion of the catheter was noticeable.Another stent graft was used with the same guide wire to perform the procedure.There was no patient involvement.
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Search Alerts/Recalls
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