Model Number 1804400-08 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/04/2022 |
Event Type
malfunction
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Event Description
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It was reported that during preparation of the 4.0 x 8 mm xience skypoint stent delivery system (sds) , when the stylet was pulled out of the sds, the stylet was noted to be broken in two pieces.Therefore, the sds was not used.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Manufacturer Narrative
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The device was returned for analysis.The reported tip separation was confirmed.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 similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely inadvertent mishandling during sheath/stylet removal caused the reported tip detachment.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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