Model Number EP003994S |
Device Problems
Break (1069); Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/28/2019 |
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 the preparation for an radiofrequency (rf) procedure, the needle scratched the inside of the sheath.There was no patient involvement.
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Manufacturer Narrative
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Product event summary: the brockenbrough needle, (b)(4) with lot number 216421581, was returned and analyzed.External visual inspection of the needle was performed and there was no issue identified.In conclusion, the reported skiving issue was not confirmed through the product analysis of the needle.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Product event summary: the transseptal needle, (b)(4).With lot number 216421581, was returned and analyzed.External visual inspection of the needle showed it was intact with no apparent issues.However, 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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