Visual inspection of the returned device revealed that the device had not been prepped prior to use.No saline was found in the balloon.The balloon's distal tip was inverted, which indicated tension was applied during pull back.The balloon was fully inflated with water and pressure was maintained.The inflation indicator performed per specification.No leaks were observed.The inflated balloon diameter was also verified in a go/no go gauge and was noted to be within specification.Based on the information provided and the investigation performed, the root cause of the reported event could have been incorrect prep of the balloon.Per the mynxgrip instructions for use (ifu), the device needs to be purged of air by drawing vacuum with 2-3 ml of sterile saline prior to use.Failure to purge the device of air during the prep phase can cause the balloon to partially collapse as the air in the system is exposed to additional compressive forces and result in the balloon pulling through the arteriotomy.There is no evidence to suggest that the mynx vascular closure device did not meet specification or perform as intended per the ifu.The review of the lhr (f1520402) indicated that the device lot met all established performance criteria prior to shipment.
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