It was reported that the procedure was performed to treat a non-calcified, mildly tortuous right coronary artery that was 80% stenosed.The 2.0x20mm mini trek balloon ruptured at 6 atms on the second inflation.The device was replaced with a new same size unspecified balloon to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Reportedly, the 2.0x20mm mini trek balloon had not been prepped (air aspiration) outside the anatomy prior to use.No additional information was provided.
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The device was returned for analysis.The reported balloon material rupture was unable to be confirmed; however there was noted outer member damage/leak.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 from this lot.It should be noted that the trek rx and mini trek rx coronary dilatation catheter instructions for use (ifu) states: caution: all air must be removed from the balloon and displaced with contrast prior to inserting into the body; otherwise, complications may occur.It is undetermined if the deviation of the ifu caused/contributed to the reported difficulties.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.
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