Catalog Number 1500225-08 |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/05/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Exemption number e2019001.The device is expected to be returned for investigation.It has not yet been received.A follow-up the device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
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Event Description
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It was reported that after removal from the foil pouch, it was noted that the sterile pouch of the 2.25x08 mm xience sierra stent was not fully sealed.The side that would normally be used to open the sterile pouch was already open.The device was not used and there was no patient involvement.A new, same size xience sierra stent was used to complete the procedure.There was no reported clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was returned for analysis.The reported unsealed device packaging 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 unsealed device packaging appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.
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Search Alerts/Recalls
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