Model Number 82096-01 |
Device Problem
Premature Activation (1484)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/20/2022 |
Event Type
malfunction
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Event Description
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It was reported that the 10x40x136 xact stent was removed from the tray and the wire of the stent at the tip of the sheath was found partially exposed; however, not flowered.It was attempted to release the knob and rotate in the opposite direction; however, the stent could not be completely retrieved into the sheath.Another stent was used to successfully complete the procedure.There were 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 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.Na.
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Manufacturer Narrative
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The device was returned for analysis.The reported premature activation was able to be 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 incidents from this lot.It is possible that inadvertent mishandling during unpackaging caused the sheath to slightly retract thus resulting in the stent to be exposed and partially deploy; however this cannot be confirmed.The investigation was unable to determine a conclusive cause for the reported difficulties.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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