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 06/14/2019 |
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 a radiofrequency (rf) procedure, skiving occurred when inserting the needle into the sheath.The sheath was replaced and the issue occurred again.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 brockenbrough needle, ep003994s with lot number 217036359, 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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Manufacturer Narrative
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Product event summary: the transseptal needle, (b)(4) with lot number 217036359, was returned and analyzed.Visual inspection of the needle showed that no issue was identified.The reported skiving issue could not be confirmed through testing; 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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