Model Number HST III SYSTEM (3.8MM) |
Device Problem
Failure to Unfold or Unwrap (1669)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/22/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Trackwise id # (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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Event Description
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The hospital reported that during a coronary artery bypass procedure, hst iii system (3.8mm) seal was properly installed in the tube at the delivery device, after the separation, the seal fail to unwrap.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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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) seal was properly installed in the tube at the delivery device, after the separation, the seal fail to unwrap.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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Manufacturer Narrative
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Internal complaint number: (b)(4).The lot # 25152041 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.The device was returned to the factory on 10/26/2020.An investigation was conducted on 11/05/2020.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed on the delivery device.The delivery device was returned outside the loading device with the white plunger fully depressed and the blue slide lock dis-engaged.The seal and tension spring assembly was observed inside the delivery tube, but not in its normal position.The tension spring assembly was not completely pushed down in the delivery tube.The ends of the tension spring assembly were sticking out of the delivery tube.The seal was observed hanging outside the delivery device with blood observed on the seal.The seal was observed to be in opened state.No visual defects were observed on the seal or tension spring assembly.The seal and tension spring assembly was removed from the delivery device.The seal was observed to be in open state, no cracks or delamination was observed.The blue tension spring assembly was observed to be attached to the seal, no detachment was observed.No measurements of the delivery tube were conducted due to the presence of blood which indicates that there was an attempt to introduce the device into the aorta.Based on the returned condition of the device, the reported failure "failure to unfold or unwrap" was not confirmed.
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Search Alerts/Recalls
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