Catalog Number M0035473080 |
Device Problem
Premature Activation (1484)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/08/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The device is not available to the manufacturer.
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Event Description
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It was reported that when the coil (subject device) was advanced in the microcatheter, the coil got stuck at the tip of the microcatheter and detached prematurely.The coil was retrieved along with the microcatheter.There were no reported clinical consequences to the patient.
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Manufacturer Narrative
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The device history record review confirms that the device met all material, assembly and performance specifications.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.Information available indicated that the device was confirmed to be in good condition prior to use.Based on the information currently available, the exact cause for the reported event cannot be determined.
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Event Description
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It was reported that when the coil (subject device) was advanced in the microcatheter, the coil got stuck at the tip of the microcatheter and detached prematurely.The coil was retrieved along with the microcatheter.There were no reported clinical consequences to the patient.
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Search Alerts/Recalls
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