Model Number 1804275-33 |
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 01/28/2022 |
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 the packaging of a 2.75x33mm xience skypoint stent delivery system (sds) was opened; however, the device in the packaging was a 2.75x38mm xience skypoint instead of a 2.75x33mm xience skypoint.A new 2.75x33mm xience skypoint was used to successfully complete the procedure.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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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 identified no similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported complaint.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.B3: date of event updated.
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Event Description
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It was reported that the packaging of a 2.75x33mm xience skypoint stent delivery system (sds) was opened; however, the device in the packaging was a 2.75x38mm xience skypoint instead of a 2.75x33mm xience skypoint.A new 2.75x33mm xience skypoint was used to successfully complete the procedure.There was no patient involvement and no clinically significant delay in the procedure.Subsequent to filing the initial mdr, the following information was received: the date of event is 01/28/2022.No additional information was provided.
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Search Alerts/Recalls
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