Model Number EP003994S |
Device Problems
Break (1069); Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/07/2018 |
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 a radiofrequency procedure, at the time of transeptal puncture, the needle was scratching inside the dilator and could not be advanced outside of the tip.The needle was replaced.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, (b)(4) with lot number 216106837, was returned and analyzed.Visual inspection of the needle showed that no issue was identified.The reported skiving issue was not confirmed through visual inspection of the product.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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Manufacturer Narrative
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Product event summary: the brockenbrough needle, (b)(4) with lot number 216106837, was returned and analyzed.Visual inspection of the needle showed that no issue was identified.The reported skiving issue was not confirmed through visual inspection of the product.The needle passed the returned product inspection.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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