Model Number HST III SYSTEM (3.8MM) |
Device Problem
Failure to Unfold or Unwrap (1669)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/25/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Trackwise id # (b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.Device discarded.
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Event Description
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The hospital reported that during a coronary artery bypass procedure, hst iii system (3.8mm) occluding umbrella failed to be fixed in the aorta, (failed to unfold and fix) and the operation was completed after replacing it with a new one, which did not cause any impact on the patient.
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Event Description
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N/a.
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Manufacturer Narrative
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Trackwise # (b)(4).Analysis of production: (3331/213/67) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis: (4109/213/67) the review of the historical data indicates that no other similar complaints was reported for the same lot number and reported failure mode.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period nov -2019 through oct-2021 was reviewed.There were no triggers identified for the review period.Communication/interviews: (4111/213/67) communication/interviews were performed to obtain all possible information.
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Search Alerts/Recalls
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