Three different pts had an 8 fr sheathless iabp catheter (datascope) inserted with immediate clotting of the arterial lumen of the iabp, thus necessitating the insertion of another arterial line on pts who had been anticoagulated on reopro or tpa. In investigating this situation facility found that their pressure tubing was not compatible with a 2 french arterial lumen. Datascope kits include five feet of special pressurized tubing for this catheter, but you must break apart your sterile transducer set to accomplish this. Even with their tubing you must frequently flush for a dampened waveform. In talking with other hosps in the tri-state area, they report the same problems with the 8 french sheathless iabp catheter. One facility's pts with this problem did have neurological problems and ct of head revealed multiple small embolic infarcts. This was not officially attributed to the iabp.

Add'l info rec'd from mfr 8/14/00: the identity of the balloon cannot be established due to the lack of reported info supplied to the fda by the rptr. It is not possible to determine if this complaint had been previously reported to datascope or if an iab was returned for evaluation.