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Model Number HST III SEAL (4.5MM), 5-PACK |
Device Problem
Unraveled Material (1664)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/12/2022 |
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.
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Event Description
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The hospital reported that during a coronary artery bypass procedure, hst iii seal (4.5mm) last one came out in a lump when pulling out klemme.A new device was inserted again, the anastomosis was performed again, and the operation was completed successfully.There is no problem for the patient.
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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 mode.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 feb-2020 through jan-2022 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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