PRESSUREWIRE¿

Additional Manufacturer Narrative

MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THE PRESSUREWIRE X, WIRELESS DEVICE MET RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT AND FAILED TO CROSS THE LESION. THE DEVICE GOT STUCK IN A 70% CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) LESION AND WAS DIFFICULT TO REMOVE WHEN THE WIRE WAS PULLED BACK. A RUN THROUGH WIRE WAS PLACED DISTAL TO IT AND PULLED BACK BUT THE WIRE TIP FRACTURED. A SECOND RUN THROUGH WIRE WAS USED TO TWIST BOTH DEVICES TO TRAP THE FRACTURED TIP. THE TIP WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT A REPLACEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS. HOWEVER, THERE WAS A DELAY WHEN THE TWO WIRES WERE SLIP DOWN AND TWIST THE "100" TIMES TO TANGLE UP THE WIRE TO REMOVE. NO ADDITIONAL INFORMATION WAS PROVIDED.

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. IN THIS CASE, BASED ON THE REPORTED INFORMATION, THE TIP SEPARATION APPEARS TO BE DUE TO CIRCUMSTANCES OF THE PROCEDURE. REPORTEDLY, WHILE ATTEMPTING TO CROSS THE 70% CALCIFIED LESION, THE PRESSUREWIRE TIP BECAME STUCK CAUSING DIFFICULTY REMOVING AND ULTIMATELY RESULTING IN SEPARATION OF THE TIP. AS A RESULT, UNEXPECTED MEDICAL INTERVENTION WAS REQUIRED TO REMOVE THE SEPARATED TIP, CAUSING DELAY IN TREATMENT. 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.