Catalog Number 1010133-30 |
Device Problem
Premature Activation (1484)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/13/2014 |
Event Type
malfunction
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Event Description
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It was reported that the procedure was to treat an anterior cerebral artery.A 7-10 x 30 mm acculink ii was being advanced over a.014" guide wire when the stent prematurely deployed.This occurred outside the patient.The handle was locked when the stent deployed.The stent and device were removed from the guide wire and a new acculink ii was successfully used to complete the procedure.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.
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Manufacturer Narrative
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(b)(4).The device was returned for investigation.A follow-up report will be submitted with all additional relevant information.
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Manufacturer Narrative
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(b)(4).Evaluation summary: the device was returned for analysis.The premature deployment was able to be confirmed as the stent was deployed and not returned.Based on a visual inspection of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query of the electronic complaint handling database revealed no other similar incidents reported from this lot.Based on the reviewed information, no product deficiency was identified.
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Search Alerts/Recalls
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