[22538]
6/3/94 - rnthey said they were using the moncrief-popovich catheter and implantation technique. When they exteriorized the catheter it started leaking. Example: one pt was diabetic and the nurse started the pt at 1500 cc exchanges and when they went to 2000 cc exchanges the catheter started to leak. They had seven total pts where they used the moncrief-popovich implantation technique and four of the seven pts leaked. 6/14/94 - surgeondr. Informed us that he put one catheter in using our implementation and it was doing fine. The second catheter they put in leaked a bit. Dr. Also informed us they were curling up the catheter and stuffin the end into a pocket made in the subcutaneous tissue. The moncrief-popovich implantation technique says to make a straiht subcutaneous tunnel and bury the portion of the catheter to be exteriorization in this tunnel. The daner of infection by curlin the end of the catheter and stuffin it in a pocket was discussed. Dr. Areed it miht be better to bury the catheter straight and requested another implantation video to view. We sent our recent research information and updated instuction rochure. 6/16/94called the rn to find out which hospital they implanted the moncrief-popovich catheter using the implantation technique at. We discover that the hospital the implanted atheir catheters at was not ordering the moncrief-popovich catheter. Rn was informed that the moncrief-popovich catheter couldn't have een used ecause the hospital does not have them in stock. Rn informed us that they were using the swanneck catheter with the moncrief-popovich implantation technique with other catheters other than the moncrief-popovich catheter. We informed rn and she said she would inform the doctors and surgeons. Invalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. There was multiple patient involvement. Number of patients involved: 7. 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 not used as labeled/indended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: no. Corrective actions: none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5