Model Number 1011344-30 |
Device Problems
Premature Activation (1484); Ambient Temperature Problem (2878)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/21/2020 |
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.
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Event Description
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It was reported that during device preparation, the acculink self-expanding stent (ses) was found to be exposed.The device was not used.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.
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Event Description
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Subsequent to the initial medwatch report, the following information was provided: it was reported that during preparation, the.014 acculink self-expanding stent (ses) was removed from the packaging, when it was noted that the temperature indicator was found to be black.The device was not used.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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Visual inspection was performed.The reported temperature indicator issue 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 other similar incidents reported from this lot.The investigation was unable to determine a conclusive cause for the reported temperature indicator issue.It is possible that the device was stored inadequately during transportation or at the account however this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.B5: description of event h6: medical device problem code 1484 - removed.
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Search Alerts/Recalls
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