Catalog Number 1500350-18 |
Device Problem
Material Separation (1562)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/30/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.
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Event Description
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It was reported that after device preparation and while backloading the device onto the guide wire, it was noted that the tip of the device was missing; therefore, the device was not used.There was no reported adverse patient effect or a clinically significant delay in the procedure.Another xience sierra was used to complete the procedure.No additional information was provided.
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Manufacturer Narrative
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The device was returned for analysis.The reported tip separation was unable to be confirmed; however, the tip was noted to be stretched.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that inadvertent mishandling during sheath/stylet removal and/or during preparation for use resulted in the reported tip separation/noted stretched tip.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Event Description
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No additional information was provided.
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Search Alerts/Recalls
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