Catalog Number 1070350-33 |
Device Problems
Difficult to Remove (1528); Difficult to Advance (2920)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/24/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of event has been estimated.The device was received.Investigation is not yet complete.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 advancement of the 3.5x33mm xience xpedition through an unspecified y adapter, the xience xpedition became stuck so both the xience xpedition and y adapter were removed.Another new y adapter and stent were used to complete the procedure.There was no clinically significant delay in procedure or adverse patient effects.No additional information was provided.
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Manufacturer Narrative
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Internal file number - (b)(4).Evaluation summary: a visual and dimensional inspection was performed on the returned device.The reported difficult to position and difficult to remove could not be tested due to the condition of the returned 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 determined the reported difficulties appear to be related to circumstances of the procedure.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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