Catalog Number 1508350-38 |
Device Problem
Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/06/2023 |
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 upon opening the package of the 3.5x38mm xience pros stent delivery system (sds), there was no stent on the delivery system nor in the package.There was no device use or patient involvement.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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The device was returned for analysis.The reported missing component was confirmed through observed conditions.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 incidents from this lot.The investigation was unable to determine a conclusive cause for the reported missing component.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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