Model Number H965SCH647120 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/14/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that inadvertent stent deployment occurred.During unpacking of a 10.0-24 carotid wallstent, it was noted that the stent was detached from the stent delivery system.The procedure was completed with another of the same.No patient complications were reported and the patient's status was stable.
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Manufacturer Narrative
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Device evaluated by mfr.: the device was returned for analysis.The stent had already been deployed and was returned with the delivery device.A visual examination identified no issues with the stent or the stent holder.The stent impression was evident on the stent holder.A visual and tactile examination found no kinks or other damage along the length of the catheter.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).
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Event Description
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It was reported that inadvertent stent deployment occurred.During unpacking of a 10.0-24 carotid wallstent¿, it was noted that the stent was detached from the stent delivery system.The procedure was completed with another of the same.No patient complications were reported and the patient's status was stable.
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Search Alerts/Recalls
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