Visual inspection was performed on the returned device.The reported separation was confirmed.The reported difficulty removing the device could not be replicated in a testing environment due to the condition of the returned device.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 and/or complaints from this lot.The reported patient effect of embolism is listed in the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use as a known patient effect.It was reported that the device was used to treat the iliac artery.It should be noted that the coronary dilatation catheters (cdc), nc trek rx instructions for use states: the nc trek rx coronary dilatation catheters are indicated for: balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion and balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction.The investigation was unable to determine a conclusive cause for the reported difficulty removing the device; however, the reported separation, removal of foreign body and additional treatment appear to be related to operational context.A conclusive cause for the reported patient effect of embolism and the relationship to the device, if any, cannot be determined.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
|