PIONEER PLUS CATHETER

Additional Manufacturer Narrative

THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER¿S POLICY. BLOCK A2-A6: NOT AVAILABLE FROM FACILITY. BLOCKS B6 & B7: NOT AVAILABLE FROM FACILITY. BLOCK C: NOT APPLICABLE FOR THIS DEVICE. BLOCK D4: SERIAL # NOT APPLICABLE FOR THIS DEVICE. BLOCKS D6 & D7: NOT APPLICABLE FOR THIS DEVICE. BLOCKS H3 & H6: THE PIONEER PLUS CATHETER WAS NOT RETURNED, THUS NO PRODUCT INVESTIGATION WAS 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 IN A THERAPEUTIC PERIPHERAL PROCEDURE IN SEVERELY CALCIFIED SFA. DURING USE, THE CATHETER WAS RECOGNIZED, HAD PARTIAL IMAGE BUT A CATHETER FAULT DETECTED ERROR MESSAGE APPEARED. THE CATHETER WAS UNPLUGGED/PLUGGED; HOWEVER, THE IMAGE WAS LOST. SINCE THE CATHETER WAS UNABLE TO CROSS THE LESION, THE PROCEDURE WAS ABORTED, AND RESCHEDULED AT A LATER DATE FOR THE ORIGINALLY PLANNED BYPASS. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED BECAUSE THE CATHETER COULD NOT BE USED; RESULTING IN A POTENTIAL FOR HARM DUE TO THE DELAY OF THE PROCEDURE.

Additional Manufacturer Narrative

BLOCKS A2, A3A & A6: PATIENT INFORMATION AVAILABLE (RECEIVED ON 27OCT2025). BLOCKS D9 & H3: THE PIONEER PLUS CATHETER WAS RETURNED FOR EVALUATION. BLOCK D10: CONCOMITANT DEVICES AVAILABLE. BLOCK H3: VISUAL INSPECTION FOUND NO UNUSUAL CHARACTERISTICS OF THE DEVICE. DURING FUNCTIONAL TESTING, THE CATHETER FAILED THE WIRE BOND, CHANNEL MATCH, AND IMAGE TESTS. WHEN THE CATHETER WAS PLUGGED INTO THE SYSTEM, A ¿NO CATHETER¿ MESSAGE WAS DISPLAYED. BLOCK H6: THE PROBABLE CAUSE OF THE ERROR MESSAGE IS DUE TO ELECTRICAL CONNECTION FAILURE ALONG THE SCANNER. MANIPULATION, IMPACT AND APPLIED PRESSURE ASSOCIATED WITH USE AND HANDLING CAN FURTHER AFFECT THE INTEGRITY OF THE DEVICE. 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.