Model Number HST III SYSTEM (3.8MM) |
Device Problem
Fitting Problem (2183)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/30/2020 |
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, during the separation, the seal is caught in the middle of the delivery device and does not come off.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, during the separation, the seal is caught in the middle of the delivery device and does not come off.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 # 25153417 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 for evaluation on 04nov2020.Photographs from the account show delivery device was outside loading device.The tension spring and seal remained inside the loading device.The blue slide lock was dis-engaged and the plunger was completely depressed.A cutter with the cap on was shown.The device was investigated on 08jan2021.Signs of clinical use with no evidence of blood were observed.Delivery device was returned inside loading device.The delivery device was removed from the loading device.The tension spring and seal remained inside the loading device.The blue slide lock was dis-engaged and the plunger was completely depressed.The seal was taken out from the loading device for inspection.There was no sign of crack/delamination on the seal.Dimensions of the delivery tube were taken.The inner diameter was measured at 0.197 inches, the outer diameter was measured at 0.220 inches.The length of the delivery tube was measured at 2.500 inches.The measurement values recorded for the delivery tube were within the tolerance specifications.Based on the returned condition of the device and evaluation results, the reported failure "fitting problem" was confirmed and analyzed failure "premature deployment" has been confirmed.
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Search Alerts/Recalls
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