Decision Report 201500312

Summary

Mrs C was referred to the Royal Infirmary of Edinburgh for a coronary angiogram and percutaneous coronary intervention (a procedure to examine the coronary arteries, and if narrowing or blockages are found, to stretch these to enable blood to flow properly). Following the procedure, Mrs C had a bleed from her femoral artery (a large artery in the thigh), and it was necessary to carry out emergency surgery to stop this.

Mrs C was concerned there was a lack of due care during the procedure, and said she had been traumatised by the procedure and suffered from flashbacks and memory loss. The board wrote to Mrs C to explain what had happened, and offered to meet with her, but she declined. The board said the bleed Mrs C experienced was a recognised complication of the procedure.

After taking independent medical advice, we did not uphold Mrs C's complaint. We found that staff carried out the procedure reasonably, and the bleed Mrs C suffered was a recognised complication of the procedure, with staff taking reasonable and appropriate action in response to this. However, the adviser noted that staff did not complete the board's pro formas for the procedure, and we were critical of this, so we made a recommendation to the board.

We also noted that the consent documentation showed Mrs C was not keen to read the information about the procedure, and there was no record that this information was given to her verbally or the key risks of the procedure discussed. While we acknowledged that Mrs C also had responsibility to ensure she understood the risks of the procedure before agreeing to it, we found that staff should have offered Mrs C the relevant information verbally (and documented this) before continuing with the procedure, so we also made a recommendation about this.

Recommendations

We recommended that the board:

• take steps to ensure the NHS Lothian pro formas for Diagnostic Cardiac Catheterisation and percutaneous coronary intervention are completed; and
• feed back our findings regarding informed consent to the staff involved.