Catalog Number 1550225-28 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/29/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Exemption number (b)(4) - 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 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 preparation, the 2.25x28mm xience sierra stent delivery system (sds) kept burping air.The sds was not used.The procedure was successfully completed with an unspecified device.There were no adverse patient effects and no 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.A visual and functional inspection was performed on the returned device.The reported leak was not 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 was unable to determine a conclusive cause for the reported leak.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
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Search Alerts/Recalls
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