(b)(4).Evaluation summary: the device was returned for evaluation.The reported deflation difficulty and wrinkled balloon was confirmed.The reported resistance with the guiding catheter could not be tested due to the condition of the returned device.Based on visual, dimensional and functional analysis of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to this complaint.A query of the electronic complaint handling database revealed no other incidents for deflation difficulty, resistance with the guiding catheter or wrinkled balloon reported from this lot.Based on the information reviewed, there is no indication of a product deficiency.Because it was reported that air aspiration was performed inside the patient, it should be noted that the preparation for use section of the nc trek coronary dilatation catheter instructions for use (ifu) states: all air must be removed from the balloon and displaced with contrast prior to inserting into the body; otherwise, complications may occur.It is unknown if the ifu deviation contributed to the reported difficulties.
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