Change in design of intra‐aortic balloon catheter

Abstract

We would like to report an incident which led us to mistakenly believe that the gas lumen insert from an intra-aortic balloon catheter (IABC) had broken in situ. A patient was admitted to the Critical Care Unit with severe cardiogenic shock. Mechanical cardiovascular support was required and an 8 Fr Co-Lumen 40 cc Intra-Aortic Balloon Catheter (Datascope Corp., Mahwah, NJ) was inserted. Once the catheter had been correctly placed, the long plastic gas lumen insert was removed and the tip was inspected to look for the two black stripes that mark the distal end (Fig. 3). These markings are provided to allow confirmation that the entire gas lumen insert has been removed. The black stripes were, however, absent. In the belief that a piece of the insert had broken off and remained in situ, we removed the IABC and inserted a second catheter. On this occasion the markings indicating complete removal of the insert were present and intra-aortic balloon counterpulsation was initiated with good effect. Subsequent inspection revealed that both inserts were of the same length. The markings on the Profile design (left) are clearly visible. The Fidelity insert (right) has no markings. Following further investigation we have established that there were two types of Datascope 8 Fr catheter available on our unit. The first variant (Profile 8 Fr) had been in use for several years and the instruction booklet supplied clearly states ‘to verify that the entire gas lumen insert has been removed look for the two black stripes at the end of the insert’. This had become our normal practice. A new catheter had been subsequently introduced (Fidelity 8 Fr) but the gas lumen insert lacks such marking at the tip. On this occasion we had used the Fidelity catheter for the initial insertion and removed it in error as we were unaware that the markings were no longer provided. The medical and nursing staff were unaware of the change in the design of the IABC gas lumen insert. In addition, the relevant section of the instruction booklet provided with the ‘Fidelity’ catheter (paragraph C4) does not mention that the markings are no longer present. As a result we removed, and wasted, the initial catheter and subjected the patient to the additional risk of a second placement. We would suggest that clinicians check carefully whether or not they should expect to find markings on the gas lumen insert prior to use.