Visual, functional and scanning electron microscopy (sem) analysis was performed on the returned device.The reported inflation issue and leak were confirmed.Analysis of the returned product indicated the balloon dilatation catheter (bdc)was returned with blood visible inside the sidearm, in between the loosely folded balloon folds and with contrast visible inside the balloon, consistent with preparation and advancement in the anatomy.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.The sem report determined the device failure may be attributed to leakage at the sidearm.No evidence of mechanical damage was observed in the dual lumen shaft at the inflation port.The positioning of the lumen at the distal adhesive area and slight gap detected in one region suggests that a potential source of leakage may possibly be related to adhesive bonding.The investigation has determined that the reported inflation issue and leak is not related to a potential product quality issue as the occurrence rate is within the acceptable range of the risk assessment.
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