Catheter not returned for review.Review of production records showed no issues and that all catheters in this lot (33) met all requirements for release.There have no other complaints associated with this lot number.A review of the balloon tubing used to manufacture the balloons in this lot of catheters was also performed.1,147 pieces of tubing were issued in lot number 103017g.No other complaints have been received on this balloon tubing lot number.Trending of complaint information shows that there have been a total of 8 balloon burst complaints since the introduction of this catheter on to the market in 1999.With sales totalling 79,442 devices from 1999 through the end of august 2019, this represents a complaint percentage of only 0.01%.A reject catheter was pulled for comparative testing, this catheter was rejected for foreign matter under sheath.Lot# y-5503 pvn229 18x4x10x8x110x.035 labeled rated burst pressure of 4.0 atm.Vp of r&d; ted dominy, tested this catheter september 20/2019, the results are below: the balloon was inflated in a body temperature water bath.Diameters were taken at 1 atm intervals.The pressure/diameter measurements were: atm, diameter, 1.0, 16.74 mm, 2.0, 17.28 mm, 3.0, 17.68 mm, 4.0, 18.22 mm, 5.0, 18.70 mm, 6.0, 18.96 mm, 7.0, 19.30 mm, 8.0, 19.72 mm, 9.0, burst.The balloon had a longitudinal tear at 9 atm, which is well above the labeled rated burst pressure of 4.0 atm.At this time, it is unknown as to what caused the balloon to burst.The additional questions asked would provide numbed with additional information for the investigation, but they have not been answered.All reviews and testing performed showed no issues with the nucleus catheter.
|