Catalog Number RSINT27526X |
Device Problem
Inflation Problem (1310)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/05/2016 |
Event Type
malfunction
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Event Description
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It was reported that the physician was attempting to use a resolute integrity rx drug eluting stent to treat a proximal lad lesion.No damage noted to device packaging and no issues were noted when removing the devices from the hoop/tray.The device was inspected with no issues noted.It was reported that the lesion was not pre-dilated.During the procedure it was reported that the device did not pass through a previously deployed stent.No resistance was encountered or excessive force used.It was reported that the physician attempted to inflate the device at nominal pressure (9atms) but the device would not inflate at all.The inflation device was check and confirmed to be working after inflating another balloon.After removal, the physician attempted to inflate the stent on the table and it would not inflate.No patient injury reported.The physician successfully completed the procedure using another resolute integrity stent.
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Manufacturer Narrative
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There were a number of kinks visible along the hypotube.The stent was correctly positioned on the delivery system balloon with no evidence of attempted expansion.The balloon pillow and shoulder folds were intact.Negative prep was performed with no issues noted.The balloon was inflated to nominal pressure (9 atms) with no issues noted and maintained pressure.The support mandrel was removed to with no leaks detected on the inner distal shaft.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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