The hospital reported that during a coronary artery bypass procedure, hst iii system (3.8mm), the aortic cutter is pushed as soon as the safety lock of the heartstring cutter is activated.Attempt made to achieve adequate hemostasis was successful.After that, only aorta cutter used new h/s to finish the operation.There is no unusual event for the patient.
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Trackwise#: (b)(4).The device was returned to the factory for evaluation on 05/16/2022.A photograph evaluation was conducted.Signs of clinical use and no evidence of blood was observed.The aortic cutter was observed to be intact, with no visual defects observed.A visual inspection was conducted on 06/01/2022.Signs of clincial use and no evidence of blood was observed.The aortic cutter was observed to be deployed, with no visual defects observed.Based on the returned condition of the device, the reported failure "premature activation" and "misfire" was not confirmed.The lot # 25161182 history record review was completed.There were ncmrs , rework, or deviations documented for the reported lot number.[(b)(4) on nov 2, 2021 at around 10:30am, moisture was observed in compressed air tubing in the bioline area of eptfe manufacturing.Condensation in air line(s) may be an indication that the air compressor, bmarm id (b)(4), may not have been producing compressed air with a dew point less than or equal to +7 degrees c as required to satisfy the validation acceptance criteria per (b)(4) compressed air distribution system oq/pq protocol, rev b, section 7.7.].Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.
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