Model Number 1804300-23 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/04/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device is expected to be returned for investigation.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 during removal of the 3.0x23mm xience skypoint stent delivery system from the dispenser hoop coil the hub separated.Another non-abbott device was used to successfully complete the procedure.There was no patient involvement and no clinically significant delay reported.No additional information was provided.
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Event Description
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It was reported that during removal of the 3.0x23mm xience skypoint stent delivery system from the dispenser hoop coil the hub separated.Another non-abbott device was used to successfully complete the procedure.There was no patient involvement and no clinically significant delay reported.3/3/2022: subsequently, after the initial report was filed it was confirmed that the proximal shaft of the xience skypoint separated and not the hub.No additional information was provided.
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Manufacturer Narrative
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The device was returned for analysis.The reported shaft 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.It is possible that inadvertent mishandling during unpackaging and/or removal from the dispenser coil resulted in the reported material separation; however this cannot be confirmed.The investigation determined a conclusive cause for the reported/noted difficulties cannot be determined.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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