Catalog Number NCSLC3520X |
Device Problem
Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/26/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The nc solarice device is considered to be the same as nc euphora with the exception of a different brand name and minor differences in the labeling.If information is provided in the future, a supplemental report will be issued.
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Event Description
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During a procedure an attempt was made to use a nc solarice rx ptca balloon catheter to treat a mildly calcified and tortuous lesion located in the distal left anterior descending artery (lad).There was no damage noted to the packaging.The balloon didn't cross the lesion.It was reported that the balloon failed to cross the lesion and deformation occurred in vivo during positioning/advancement.It was stated that the event was due to use of the device in difficult lesion morphology/anatomy, i.E.The event was procedural related and not device related.The patient was reported to be alive with no injury.
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Manufacturer Narrative
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Product analysis summary: a sheath and stylette were in place on the device.The balloon folds were intact, inflation had not been performed.There was no deformation evident to the balloon.No deformation was evident to the distal tip.The inner lumen patency was verified with a 0.015 inch mandrel.There was no damage evident to the remainder of the device.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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