Model Number H965SCH647070 |
Device Problems
Device Damaged Prior to Use (2284); Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/11/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Age at time of event: 18 years or older.(b)(4).
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Event Description
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It was reported that inadvertent stent deployment occurred.A 8.0-21 carotid wallstent¿ was selected to treat the lesion.However, during preparation, the stent was automatically released when the physician was preparing to flush.The device was not used and the procedure was completed with another of the same device.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 complaint device was returned for analysis.The stent had detached from the device and was returned separately with the delivery device.A visual and tactile inspection identified no issues along the length of the device.The stent was visually inspected with no issue noted.No issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).
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Event Description
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It was reported that inadvertent stent deployment occurred.A 8.0-21 carotid wallstent¿ was selected to treat the lesion.However, during preparation, the stent was automatically released when the physician was preparing to flush.The device was not used and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
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Search Alerts/Recalls
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