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 06/06/2019 |
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, the needle was unable to be removed from the sheath.It was noted that the dilator was not functioning properly due to plastic pieces blocking the dilator.A second attempt was made with a new sheath without resolve.The sheath was replaced with a competitor product.The case was completed with rf.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 216980246, 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.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 216980246, was returned and analyzed.External visual inspection of the needle was performed and there was no issue 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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