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 03/08/2018 |
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radiofrequency (rf) ablation procedure, difficulty was observed when the needle was advanced into the sheath.The needle was retracted, and plastic pieces were removed from the inner surface of the sheath dilator.The needle and sheath were replaced with resolve, and the case was completed with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 device was returned and analyzed.Visual inspection of the needle was completed and no issues were found.Evidence of skiving was observed; however, the sheath and needle were found to meet manufacturing requirements.No manufacturing defects were found on the arrive sheath, dilator or needle.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 214452316, was returned and analyzed.There were no anomalies found.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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