PRESSUREWIRE¿

Additional Manufacturer Narrative

A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED PEELED COATING AND USE OF DEVICE PROBLEM WERE NOT ABLE TO BE CONFIRMED; HOWEVER, THE PROXIMAL TUBE COATING WAS OBSERVED TO BE SCRATCHED. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. BASED ON THE REPORTED INFORMATION AND THE OBSERVATIONS FROM THE RETURNED ANALYSIS, THE INVESTIGATION DETERMINED THAT THE REPORTED PEELED/DELAMINATED COATING AND USE OF DEVICE PROBLEM APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THE GUIDEWIRE WAS RETURNED WITH KINKS AND BENDS, AND THERE WERE SCRATCHES NOTED TO THE PROXIMAL TUBE COATING IN THE AREA OF EXPECTED TORQUE DEVICE USE. IN THIS CASE, IT IS LIKELY THAT THE GUIDEWIRE DAMAGE WAS CAUSED BY THE USE OR HANDLING TECHNIQUES EMPLOYED. WHILE THERE WAS NO PEELING NOTED TO THE GUIDEWIRE, IT IS LIKELY THAT THE USER INTERPRETED THE SCRATCHED COATING AS PEELING. INFORMATION FROM THE FIELD STATED THAT THE PRESSUREWIRE WAS USED WITH A 5F GUIDING CATHETER. IN THIS CASE, IT COULD NOT BE DETERMINED IF USING A 5F GUIDING CATHETER CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTIES. BASED ON THE RESULTS OF THE COMPLAINT INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

Description of Event or Problem

IT WAS REPORTED THAT THE PRESSUREWIRE X, WIRELESS DEVICE WAS TO BE USED IN THE LEFT ANTERIOR DESCENDING (LAD) LESION. IT WAS NOTED THAT A 5FR SHEATH WAS USED. HOWEVER, THE SHAFT COATING WAS PEELING DURING INSERTION. ALSO, TORQUE MANIPULATION COULD NOT BE APPLIED. THEREFORE, THE DEVICE WAS REMOVED AND THE PROCEDURE COMPLETED WITHOUT USING A REPLACEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. H6: MEDICAL DEVICE PROBLEM CODE: 2017 LESS THAN 6 FR GUIDE CATHETER USED.