PIONEER PLUS CATHETER

Additional Manufacturer Narrative

BLOCK H3: THE PIONEER PLUS CATHETER WAS RETURNED FOR EVALUATION WITHOUT THE NON-PHILIPS GUIDEWIRE. VISUAL INSPECTION FOUND A ZIPPER TEAR FROM THE GUIDEWIRE EXIT PORT TO THE DISTAL SLEEVE, AND A PORTION OF THE POLYAMIDE WAS EXPOSED AND LIFTED. DURING FUNCTIONAL TESTING, THE CATHETER FAILED THE GUIDE WIRE MOVEMENT TEST DUE TO RESISTANCE NOTED AT THE DISTAL TIP. BLOCK H6: THE PROBABLE CAUSE OF THE REPORTED FAILURE IS LIKELY DAMAGED DURING USE HANDLING. MANIPULATION, STRAIN, 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.

Description of Event or Problem

IT WAS REPORTED THAT A PIONEER PLUS CATHETER WAS USED IN A PERIPHERAL PROCEDURE IN A SEVERELY CALCIFIED SFA. DURING ADVANCEMENT OVER A NON-PHILIPS GUIDEWIRE, RESISTANCE WAS ENCOUNTERED AND COULD NOT BE ADVANCED FURTHER. AN ATTEMPT WAS MADE TO REMOVE THE CATHETER WITH THE INTENTION OF PRE-DILATING THE SUB-INTIMAL CHANNEL; HOWEVER, THE CATHETER BECAME STUCK ON THE GUIDEWIRE, THUS WAS REMOVED TOGETHER. UPON REMOVAL, IT APPEARED THAT THE GUIDEWIRE TORE THROUGH PART OF THE CATHETER EXIT PORT. ON THE TABLE, WHEN TRYING TO REMOVE THE CATHETER FROM THE GUIDEWIRE, THE GUIDEWIRE BROKE. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS BROUGHT BACK AT A LATER DATE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE PIONEER PLUS CATHETER AND GUIDEWIRE WERE REMOVED AS A SYSTEM, AND THE PATIENT WAS BROUGHT BACK AT A LATER DATE, RESULTING IN A DELAY OF THE PROCEDURE.

Additional Manufacturer Narrative

THIS COMPLAINT WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER¿S POLICY. 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.