[837]
During the insertion of a right subclavian perma-cath dialysis catheter, a j wire (guidewire) was inserted into the superior vena cava. The dilator & sheath were passed over the j wire with some difficulties encountered, requiring removal of the j wire and reinsertion of the needle over the cutoff portion of the j wire. A new j wire was inserted & reapplication of dilator & sheath was acheived. The insertion of the perma-cath catheter was completed but upon removal of the j-wire significant resistance was encountered. X-ray revealed good position of the perma-cath catheter but a portion of the j wire was lodged in the superior vena cava and extended into the jugular vein. Patient was transferred to ohsu/interventional radiology same day for successful retrieval of j wire in total. Returned to agh same daydevice 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, other, other, invalid data. Results of evaluation: unanticipated short term complication of procedure. Conclusion: there was no device failure. Certainty of device as cause of or contributor to event: no. Corrective actions: device discarded, other. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5