The device was not returned for evaluation.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 air embolism and angina is listed in the coronary dilatation catheters (cdc), nc trek rx, global, instructions for use as a known patient effect.The investigation was unable to determine a conclusive cause for the reported complaint; however, the reported additional treatment and hospitalization appear to be related to circumstances of the procedure.A conclusive cause for the reported patient effects of air embolism, angina and cardiac arrest 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.Attachment: medwatch report #mw5097625.
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