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 07/26/2019 |
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 procedure, the sheath was flushed and when introducing the stylet and needle through the sheath, pieces of plastic came outside the sheath indicating that the needle was being scratched against the interior of the sheath and tearing it apart.The pieces of plastic were visible.The curvature of the needle was not accentuated.Several sheaths were tried, and the issue remained persistent.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 217387547, 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, ep003994s with lot number 217387547, 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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Search Alerts/Recalls
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