Model Number 1804300-18 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/25/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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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During inventory clearance of the hospital it was noted that a 3.0x18mm xience skypoint had a different lot number between the manufacturing label and the (b)(6) label of the xience skypoint.The device was not unpacked and not used.The manufacturing label has lot number 0090841 and the (b)(6) label has 0090741.There was no patient involvement and no clinically significant delay.No additional information was provided.
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Manufacturer Narrative
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The device was returned for analysis.The reported labeling problem 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 did not indicate a lot specific quality issue.The investigation determined the reported labeling issue appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.The xience skypoint device is not currently commercially available in the us; however, it is similar to a device sold in the us.
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Event Description
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It was reported that during inventory clearance of the hospital it was noted that a 3.0x18mm xience skypoint had a different lot number between the manufacturing label and the japanese label of the xience skypoint.The device was not unpacked and not used.The manufacturing label has lot number 0090841 and the japanese label has 0090741.There was no patient involvement and no clinically significant delay.No additional information was provided.Based on re-review of this event, this event would not have been reportable because the device marking/labeling issue of lot # does not impact the use of the device and there is no potential for a serious injury.However, since the initial report has already been filed, this event must remain reportable.
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Search Alerts/Recalls
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