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 03/14/2019 |
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 procedure, the ¿flush¿ had stopped when the needle was inserted into the sheath.It was noted that needle was removed from sheath, and skiving occurred.The needle was replaced with resolve.The case was completed with radiofrequency.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, (b)(4) with lot number 216513846, was returned and analyzed.External visual inspection of the needle showed the device was intact with no apparent issues.In conclusion, the reported skiving issue was not confirmed through product analysis.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 216513846, was returned and analyzed.External visual inspection of the needle showed the device was intact with no apparent issues.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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