Catalog Number 1070350-12 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/01/2021 |
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 once the 3.50x12mm xience xpedition stent delivery system (sds) was removed "out of the ring" [hoop coil], it was observed the sds was separated into two separated pieces.An unspecified device was used to successfully complete the procedure.There was no patient involvement and no clinically significant delay reported.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 material separation was confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.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 material separation.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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