Model Number 1011344-40 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/02/2021 |
Event Type
malfunction
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Event Description
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It was reported during preparation of the 7-10x40mm rx.014 acculink self-expanding stent system (sess), the device was being flushed and liquid sprayed out the side of the device (hub).Another same size acculink 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 received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
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Manufacturer Narrative
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The device was returned for analysis.The reported leak 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 repackaging and/or during preparation for use resulted in the noted gap between handle halves; thus resulting in the reported leak; however this cannot be confirmed.The investigation determined a conclusive cause for the reported/noted difficulties cannot be determined.The noted multiple bends and kinks on the entire length of the shaft likely occurred due to handling or during packing for return analysis.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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