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Model Number UNK60 |
Device Problems
Break (1069); Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
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Event Description
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It was reported that shaft separation and partial deployment of the stent occurred.The target lesion was located in the carotid artery.A carotid wallstent monorail was advanced for treatment.However, halfway through deployment of the stent, the outer catheter separated approximately 10cm from the tip.The stent was able to be recaptured and the device was removed.The procedure was completed with a different device.No patient complications were reported and the patient's status was fine.
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Search Alerts/Recalls
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