Catalog Number 22438-19 |
Device Problems
Detachment Of Device Component (1104); Improper or Incorrect Procedure or Method (2017)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/16/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4): incorrect anatomy.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.
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Event Description
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It was reported that during use of the emboshield nav6 embolic protection device (epd) in an intervention of an acute closure of the bypass graft, the bare wire was noted to be separated.A different epd filter was used in the procedure without issue.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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(b)(4).A visual inspection was performed on the returned device.The reported core separation was not confirmed; however, returned device analysis noted that the coils were stretched.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.The emboshield nav6 embolic protection system electronic instruction for use is indicated for use within the carotid arteries.Use in the coronary bypass graft does not appear to have contributed to the noted stretched coils.The investigation determined the reported difficulties and noted stretched coils appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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