Model Number 26921 |
Device Problems
Premature Activation (1484); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/04/2024 |
Event Type
malfunction
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Event Description
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It was reported that the stent was partially deployed.A 5 x 40 x 130 innova self-expanding stent was selected for use.During unpacking, it was found that the stent was partially deployed without removing the safety lock from the handle.The procedure was completed with another of the same device.No complications were reported, and the patient was stable.
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Manufacturer Narrative
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Device evaluated by mfr.: the device was returned for analysis.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the stent is partially deployed approximately 1cm from the middle sheath.There is a kink to the outer sheath at the nosecone.Microscopic examination revealed no additional damages.The lock and pull rack are still in the manufactured location.Inspection of the remainder of the device, revealed no other damage or irregularities.
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Event Description
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It was reported that the stent was partially deployed.A 5 x 40 x 130 innova self-expanding stent was selected for use.During unpacking, it was found that the stent was partially deployed without removing the safety lock from the handle.The procedure was completed with another of the same device.No complications were reported, and the patient was stable.
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Search Alerts/Recalls
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