PIONEER PLUS CATHETER

Additional Manufacturer Narrative

THIS COMPLAINT WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER¿S POLICY. BLOCKS A2-A6: NOT AVAILABLE FROM FACILITY. BLOCKS B6 & B7: NOT AVAILABLE FROM FACILITY. BLOCK C: NOT APPLICABLE FOR THIS DEVICE. BLOCKS D6 & D7: NOT APPLICABLE FOR THIS DEVICE. BLOCK H3: THE PIONEER PLUS CATHETER WAS RETURNED INTACT TO A NON-PHILIPS GUIDEWIRE. VISUAL INSPECTION FOUND A RETRACTED NEEDLE AND A PORTION OF THE DISTAL SLEEVE LIFTED. DURING FUNCTIONAL TESTING, AN ATTEMPT WAS MADE TO REMOVE THE GUIDEWIRE, BUT COULD NOT BE REMOVED. ADDITIONALLY, A NEEDLE DEPLOYMENT/RETRACTION TEST WAS PERFORMED; HOWEVER, IT FAILED DUE TO RESISTANCE. ALTHOUGH THE NEEDLE WAS RETRACTED WHEN RECEIVED FOR EVALUATION, THE CUSTOMER CONFIRMED THAT THE NEEDLE WAS EXPOSED WHEN REMOVED FROM THE PATIENT. BLOCK H6: THE PROBABLE CAUSE OF THE NEEDLE UNABLE TO DEPLOY/RETRACT IS DUE TO MECHANICAL FAILURE. DEVICE MANIPULATION, IMPACT, AND HANDLING CAN FURTHER AFFECT THE INTEGRITY OF THE DEVICE. 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. DURING USE, THE NEEDLE WAS UNABLE TO RETRACT. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION OBTAINED ON 03OCT2025: AFTER SEVERAL ATTEMPTS TO RETRACT THE NEEDLE, THE DECISION WAS MADE TO REMOVE THE ENTIRE SYSTEM FROM THE PATIENT. AFTER REMOVAL, THE CATHETER WAS MANIPULATED MULTIPLE TIMES AND WAS FINALLY ABLE TO RETRACT THE NEEDLE. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO A SHARP EDGE. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WAS TO RECUR.

Additional Manufacturer Narrative

BLOCK D10: RECEIVED GUIDEWIRE, INTRODUCER SHEATH, AND GUIDE CATHETER MANUFACTURER NAME AND SIZE. 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.