Model Number SECX-10-60-135 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/25/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned to manufacturing facility for analysis.The distal portion of the stent was protruding out from the distal end of the catheter outer sheath approximately 2mm.There was damage to tip noted.Evidence of biologic was seen within the catheter and on y-manifold.The device was flushed and a 0.014" guide wire loaded.Maximum peak force required to deploy stent in deployment apparatus to be less that 3lbs and device was unable to deploy.The inner shaft (proximal grip) exhibited a bend at 3.53lbs.There was no damage noted to the inner distal assembly.There was no damage to the stent condition.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Physician was attempting to treat the mid carotid artery using protege stent.The sheath was so hard that the protege which was delivered but could not be deployed.A new product with the same size was used without issues and the procedure was completed without any issues.There was no patient injury reported.
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Search Alerts/Recalls
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