The hospital reported that during a coronary artery bypass procedure, hst iii system (4.3mm) cracks appeared after the sealing umbrella was loaded, and the same product was replaced to complete the operation, without causing harm to the patient.
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Trackwise #(b)(4).Updated sections: b4, g4, g7, h2, h6, h10.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 (b)(6) 2020 through (b)(6) 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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