Catalog Number 1011922-060 |
Device Problem
Premature Activation (1484)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/16/2022 |
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 that during preparation of the 7.00x60mm absolute pro self expanding stent system (sess), while still in the locked position the stent was noted to be unsheathed/exposed but not opening.The sess was not used in the procedure.There was no patient involvement and no clinically significant delay reported.No additional information has been provided.
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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 during removal of the stylet, the tip was inadvertently pulled causing the stent to slightly pull out and prematurely deploy; however this cannot be confirmed.The investigation determined a conclusive cause for the reported/noted difficulties cannot be determined.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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