Model Number EP003994S |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/23/2019 |
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, skiving occurred when the needle was inserted into a sheath.The products were flushed and were continued to be used in the procedure.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 needle (b)(4) with lot number 215815543 was returned and analyzed.Visual inspection of the needle indicating the device was intact with no apparent issues.In conclusion, the reported skiving issue could not be confirmed through testing.The needle passed the returned product inspection as per specification.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, skiving occurred when the needle was inserted into a sheath.The products were flushed and were continued to be used in the procedure.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 transseptal needle, (b)(4) with lot number 215815543, was returned and analyzed.Visual inspection of the needle indicating 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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