PRESSUREWIRE¿

Description of Event or Problem

REPORTEDLY, THE PRESSUREWIRE X - WIRELESS DEVICE WAS USED DURING THE PROCEDURE, WITH RESISTANCE FELT DURING ADVANCEMENT AND THE DEVICE BECAME BENT. UPON REMOVAL, THE PTFE COATING WAS FOUND TO HAVE PEELED OFF, AND A SEPARATION WAS NOTED. THEREFORE, THE DEVICE WAS REMOVED AND ANOTHER PRESSUREWIRE X, WIRELESS DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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.

Additional Manufacturer Narrative

A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED PEELED/DELAMINATED COATING AND DIFFICULTY TO ADVANCE WERE NOT ABLE TO BE CONFIRMED; HOWEVER, THE REPORTED DEFORMATION DUE TO COMPRESSIVE STRESS (KINKS/BENDS) AND MATERIAL SEPARATION WERE ABLE TO BE CONFIRMED VISUALLY. 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, DIFFICULTY TO ADVANCE, BEND, AND MATERIAL SEPARATION APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THE GUIDEWIRE WAS RETURNED WITH KINKS AND BENDS, WHICH CAUSED A MATERIAL SEPARATION OF THE PROXIMAL TUBE; HOWEVER, THERE WAS NO PEELING OR DELAMINATION OF THE PROXIMAL TUBE COATING. IN THIS CASE, IT IS LIKELY THAT THE PATIENT¿S ANATOMICAL CONDITIONS OR THE USE TECHNIQUES EMPLOYED CAUSED THE REPORTED DIFFICULTY TO ADVANCE AND RESULTING GUIDEWIRE DAMAGE AND SEPARATION. 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.