Model Number HST III SYSTEM (4.3MM) |
Device Problem
Fitting Problem (2183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/02/2021 |
Event Type
malfunction
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Event Description
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Related to (b)(4).The hospital reported that during a coronary artery bypass procedure using hst iii system (4.3mm), in steps 3 and 4 of the hsiii procedure, the umbrella wouldn't stay inside the tube and deployed in the holder.(sn (b)(4)) they then used a third one (sn (b)(4)) that performed perfectly.They performed the proximal anastomose without problems.No patients effects.
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Manufacturer Narrative
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(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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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 dec-2019 through nov-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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