Catalog Number 1070250-38 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/19/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.Na.
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Event Description
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It was reported that while unpacking the device, before use, a 2.5x38mm xience xpedition drug eluting stent (des) package was opened for use, but the stent inside the package was a 2.5x33mm sized xpedition.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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A visual inspection was performed on the returned device.The reported device markings/labelling problem was not confirmed as the labeling on the pouch matched the labeling on the device.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 device markings/labelling problem.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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