[17826083]
Patienthas a history of metastatic colon carcinoma. On 6/23/92, patient ghad insertion of a subcutaneous venous access port. She has received a year of chemotherapy through the port without difficulty. On 7/2/93 port could not be accessed at oncology physician's office. Patient was also complaining of cardiac arrthymia. Brough to hospital for evaluation. Under fluoroscopy noted failed infuse-a-port. Segment of catheter seen broken ioff and in heart. Under fluoroscopy, going up through the groin to the vena cava, the 6cm catheter piece was retreived percutaneously, slowly and carefully. The patient suffered no long-term ill effects. She was, however, kept in the hospital over night for observation. The catheter was sheared approximately 6 cm from the end. The port had been placed in the subclavian side on the leftinvalid data - regarding single use labeling of device. Patient medical status prior to event: satisfactory 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. Results of evaluation: none or unknown. Conclusion: invalid data. Certainty of device as cause of or contributor to event: yes. Corrective actions: invalid data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5