Model Number EP003994S |
Device Problems
Break (1069); Use of Device Problem (1670)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/18/2017 |
Event Type
malfunction
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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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Event Description
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It was reported that during an radiofrequency procedure, during the transseptal procedure, when the needle was removed from the introducer, there was material on the tip of the needle.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: the transseptal needle, ep003994s was not returned.While no product was returned, an analysis of an image showed evidence of skiving.It is plausible that skiving occurred as there is a compatibility issue with the needle and a competitor sheath.The cause of the issue was not established.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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