This report was received from numed's foreign distributor in (b)(6).
It was sent to them from tga, as it was reported to the regulatory body.
The reporter is marked as confidential so the distributor is unable to follow up with the facility to obtain more information.
There is very little information given within the report from the tga.
A review of the device history record was performed and no issues were found.
All devices within the lot met all requirements for release and distribution.
There have been no other complaints associated with this lot number.
A review of the balloon material used shows there are no other complaints associated with the balloon material used to manufacture the balloons used on this lot of catheters.
It was noted in the tga report that this device was being used for aortic valvuloplasty which is an off-label use.
This device is only approved for use in pulmonary valvuloplasty.
It is unknown as to what pressure this balloon catheter was taken to and what pressure the balloon burst at.
A comparative catheter was tested.
This catheter was the same catalog number, but a different lot number.
The balloon was immersed in a body temperature water bath and inflated until it failed.
The comparative catheter did not burst until 3.
5 atm, which is more than the labeled rated burst pressure of 2 atm.
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