Model Number EP003994S |
Device Problems
Break (1069); Mechanical Problem (1384)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/28/2014 |
Event Type
malfunction
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Event Description
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It was reported that when the physician was inserting the needle into a competitor transseptal sheath, a piece of plastic from the sheath "went out." no patient complications have been reported as a result of this event.
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Manufacturer Narrative
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The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.(b)(4).
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Manufacturer Narrative
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Evaluation summary: analysis was performed and no anomalies were found.
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Manufacturer Narrative
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Product event summary: the transseptal needle, ep003994s with lot number 207837995, was returned and analyzed.Analysis was performed and no anomalies were found.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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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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