PRESSUREWIRE¿

Description of Event or Problem

IT WAS REPORTED THAT DURING PREPARATION WITH THE PRESSUREWIRE X, WIRELESS DEVICE, IT WAS FOUND THE GUIDE COATING HAD PEELED OFF. THEREFORE, THE DEVICE WAS NOT USED IN THE PATIENT AND ANOTHER PRESSUREWIRE X, WIRELESS DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT 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.

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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 INFORMATION PROVIDED, A DEFINITIVE CAUSE FOR THE REPORTED PEELED/DELAMINATED COULD NOT BE DETERMINED. IN THIS CASE, IT IS POSSIBLE THAT THE TORQUE DEVICE HAD INADVERTENTLY SCRAPED THE GUIDEWIRE¿S PROXIMAL TUBE COATING, OR THERE WAS A COSMETIC DEFECT TO THE COATING OF THE PROXIMAL TUBE, WHICH CAUSED THE REPORTED PEELING; HOWEVER, THESE CONDITIONS COULD NOT BE CONFIRMED. 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.