Model Number 26926 |
Device Problem
Entrapment of Device (1212)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/14/2019 |
Event Type
malfunction
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Event Description
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It was reported that the device became stuck on the guidewire.An innova 6x150x130 self expanding stent was selected to be implanted in the superficial femoral artery (sfa).After the stent was successfully deployed, the catheter became stuck on the wire upon retrieval.The deployment system and wire were successfully removed from the patient.There were no patient complications and the patient is fine.
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Manufacturer Narrative
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Device analysis by mfr: the returned product consisted of an innova self-expanding stent system with an unknown 0.035" guidewire inside the device.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the pull rack is bent.There is a kink to the outer sheath at the nosecone.Microscopic examination revealed no additional damages.The wire was unable to be removed initially so it was x-rayed to see if there were any damages in the handle.No additional damages were seen so the device was placed in a water bath.After soaking, the wire was able to be removed.Inspection of the remainder of the device presented no other damage or irregularities.
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Event Description
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It was reported that the device became stuck on the guidewire.An innova 6x150x130 self expanding stent was selected to be implanted in the superficial femoral artery (sfa).After the stent was successfully deployed, the catheter became stuck on the wire upon retrieval.The deployment system and wire were successfully removed from the patient.There were no patient complications and the patient is fine.
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Search Alerts/Recalls
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