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 06/05/2018 |
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, the brockenbrough needle was in a competitor introducer and scratched the in ner surface of the introduce so the guide wire lumen could not reach the tip.The product was removed from the patient and plastic fragments of the inner surface of the introducer were found.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 device was returned and analyzed.Visual inspection was completed and there no issue was discovered.Also, the tip of the needle was intact and an unusual edge was not observed.In conclusion, the reported skiving issue was not confirmed through the product analysis.The device passed the visual inspection test.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 214704459, was returned and analyzed.Visual inspection was completed and there no issue was discovered.Also, the tip of the needle was intact, and an unusual edge was not observed.The reported skiving issue was not confirmed.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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