[20770792]
During the performance of a right heart catherization procedure, the balloon failed to deflate. Malfunction was noticed as the physician was attempting to re-position the catheter. Negative and positive pressure was applied (via syringe) in an attempt to deflate the balloon. The balloon detached as the catheter was being removed. Removal procedure attempted on 8/5/93, but was unsuccessfuldevice labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: component failure, balloon. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: none or unknown. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5