PRESSUREWIRE¿

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. INFORMATION FROM THE FIELD STATED THAT THE PRESSUREWIRE WAS USED WITH A GUIDING CATHETER SMALLER THAN 6F. THE PRESSUREWIRE INSTRUCTIONS FOR USE (IFU) DIRECTS THE USER TO USE THE PRESSUREWIRE GUIDEWIRE IN CONJUNCTION WITH A 6F (2 MM DIAMETER) GUIDING CATHETER. IN THIS CASE, IT COULD NOT BE DETERMINED IF USING A SMALLER SIZED GUIDING CATHETER CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTIES. BASED ON THE INFORMATION RECEIVED, THE INVESTIGATION DETERMINED THAT THE REPORTED DIFFICULTY TO ADVANCE AND DIFFICULTY TO REMOVE FROM THE PATIENT APPEAR TO BE RELATED TO OPERATIONAL CONTEXT. IN THIS CASE, IT IS LIKELY THAT THE PATIENT¿S ANATOMICAL CONDITIONS, OR THE CONDITIONS OF THE GUIDEWIRE BEING EMPLOYED, CAUSED THE REPORTED DIFFICULTY TO ADVANCE AND REMOVE THE CATHETER FROM THE PATIENT. IT COULD NOT BE DETERMINED IF USING A SMALLER SIZED 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 INTENDED TO BE USED IN A LEFT ANTERIOR DESCENDING ARTERY (LAD) LESION. IT WAS NOTED A LESS THAN 6F SHEATH WAS USED. DURING ADVANCEMENT, THE DEVICE DID NOT ADVANCE SMOOTHLY WHEN PUSHED, AND RESISTANCE WAS NOTED DURING WITHDRAWAL. THE DEVICE WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER PRESSUREWIRE X DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.