The device was returned for analysis.The reported deformation due to compressive stress/kink was able to be confirmed.The reported material rupture was unable to be confirmed.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: prior to use, examine all equipment carefully for defects.Examine the dilatation catheter for bends, kinks, or other damage.Do not use any defective equipment.The reported material rupture was not confirmed and the deviation of the ifu does not appear to have caused/contributed to the reported difficulties.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during unpacking and/or preparation for use inadvertent mishandling resulted in the reported/noted deformation due to compressive stress/ outer member and bayonet kinks.Further mishandling resulted in the noted multiple hypotube bends.The reported material rupture was unable to be confirmed.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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