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Model Number HST III SYSTEM (3.8MM) |
Device Problems
Fitting Problem (2183); Activation Problem (4042)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/16/2022 |
Event Type
malfunction
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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), after punching with aortic cutter during off pump cabg, in the process of inserting the delivery system and shooting, the seal loosens in a situation where the plunger button is not pressed well.It was not opened with no shooting.The surgeon placed a finger over the seal and aortomomy, to anchor it in place.The blue slide was in a unlock state.The seal made contact with the patient's aorta but it did not exit the delivery tube on actuation.They replaced with a new product of the same type.After that, the operation was successfully completed without additional bleeding or adverse reactions in the patient.
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Manufacturer Narrative
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(b)(4).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.
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Manufacturer Narrative
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Trackwise#: (b)(4).Corrected sections: h6--updated from code 2183 to 4042.The device was returned to the factory for evaluation on 06/22/2022.Photographs were provided by the account.A photographic inspection was conducted.Signs of clinical use and evidence of blood was observed on the delivery device.The white plunger was observed to be depressed.The blue safety lock was not observed in the photographs.The seal was also not observed in the photographs.An investigation was conducted on 07/20/2022.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed.The delivery device was returned outside the loading device.The white plunger was fully depressed and the blue safety lock was off, which allows for the white plunger to be depressed.Blood was observed on the delivery device indicating an attempt was made to introduce the device into the aorta, hence no measurements of the delivery device were taken.The seal and tension spring assembly was also returned outside the devices.The seal was observed to be in a fully opened state, detached from the tension spring assembly.The seal was observed to be unraveled, and had blood on it, which indicates the seal was introduced into the aorta.No other visual defects were observed.Based on the returned condition of the device, the reported failure "activation problem" was not confirmed.The lot # 25160840 history record review was completed.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 batch manufacturing process and the reported failure.
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Event Description
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N/a.
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Search Alerts/Recalls
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