[951]
On 11/21/91 a physician attempted to change the patient's left subclavian triple lumen catheter to a swan ganz catheter by threading a guidewire through the existing subclavian line, removing the subclavian line and threading the swan ganzcatheter over the guidewire. In attempting this procedure, the physician inserted a guidewire into the distal port of the catheter. The physician met resistance while threading the guidewire, therefore, he immediately stopped the procedure, removed the guidewire, and removed the multi-lumen catheter and discarded it. On 12/6/91 thepatient had a chest x-ray performed which revealed a foreign body int he patient's left subclavian vein. The patient was taken to the special procedure area of the radiology department where, under flouroscopic guidance, the foreign body was removed and determined to be a piece of the triple lumen catheter. Visual inspection of the portion of the catheter removed from the patient failed to reveal the cause of the incident. Device labeled for single use. Patient medical status prior to event: critical 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 not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5