PIONEER PLUS CATHETER

Additional Manufacturer Narrative

THIS COMPLAINT WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER¿S POLICY. BLOCKS A2, A3B, A4, A5, & A6: THE PATIENT'S DOB, GENDER, WEIGHT, ETHNICITY, AND RACE ARE UNKNOWN. THIS INFORMATION WAS NOT AVAILABLE FROM THE FACILITY. BLOCK C: NOT APPLICABLE FOR THIS DEVICE. BLOCKS D6 & D7: NOT APPLICABLE FOR THIS DEVICE. BLOCKS H3 & H6: THE PIONEER PLUS CATHETER WAS NOT RETURNED FOR EVALUATION, THUS NO PRODUCT INVESTIGATION PERFORMED. BLOCKS H7, H9 & H10: DO NOT APPLY TO THIS SUBMISSION. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.

Description of Event or Problem

IT WAS REPORTED THAT A PIONEER PLUS CATHETER WAS USED FOR A PERIPHERAL PROCEDURE IN A CTO LESION. DURING USE, THE CATHETER BECAME STUCK ON A NON-PHILIPS GUIDEWIRE AND HAD TO BE REMOVED TOGETHER. A NEW GUIDEWIRE WAS INSERTED, AND UPON ADVANCING A NEW PIONEER PLUS CATHETER, THE CATHETER COULD NOT BE RECOGNIZED. AN ATTEMPT TO DISCONNECT/RECONNECT AND SHUTTING/RESTARTING THE SYSTEM WAS PERFORMED WITH NO SUCCESS. THE PROCEDURE WAS ABORTED DUE TO THE FAILURE ON THE SECOND ATTEMPT AND PATIENT EXPERIENCED A DISSECTION. THE PATIENT WILL BE BROUGHT BACK AT A LATER DATE. THE PATIENT REMAINS STABLE WITH NON-HEALING WOUNDS. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE PATIENT EXPERIENCED A DISSECTION, CATHETER AND GUIDEWIRE WERE REMOVED AS A SYSTEM, AND THE PATIENT WILL BE BROUGHT BACK FOR FURTHER TREATMENT; RESULTING IN A DELAY OF THE PROCEDURE.