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. IN THIS CASE, BASED ON THE REPORTED INFORMATION, THE TIP SEPARATION APPEARS TO BE DUE TO CIRCUMSTANCES OF THE PROCEDURE. IT IS LIKELY THAT THE TIP OF THE PRESSUREWIRE BECAME COMPROMISED WHILE ADVANCING IN THE CHALLENGING LEFT ANTERIOR DESCENDING ARTERY (LAD), WHICH WAS DESCRIBED AS STENOSED, CALCIFIED, AND SLIGHTLY TWISTED IN THE MID-SECTION, AND DURING REMOVAL, THE SEPARATION OCCURRED. AS A RESULT, UNEXPECTED MEDICAL INTERVENTION WAS REQUIRED TO REMOVE THE TIP; HOWEVER, THE TIP WAS UNABLE TO BE REMOVED AND REMAINED LODGED IN THE ANATOMY. 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. D9 CORRECTION: DEVICE AVAILABLE FOR EVALUATION UPDATED FROM YES TO NO.

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 PROCEDURE WAS TO DIAGNOSE A LEFT ANTERIOR DESCENDING ARTERY (LAD) LESION WITH CALCIFICATION AND WAS SLIGHTLY TWISTED IN THE MID-SECTION. THE PRESSUREWIRE X WIRELESS DEVICE WAS BEING USED DURING THE PROCEDURE. THE DEVICE PASSED THROUGH THE STENOSIS AND WAS REMOVED WITHOUT FORCE; HOWEVER, THE DISTAL TIP SEPARATED. AN ATTEMPT WAS MADE TO RETRIEVE THE TIP BUT WAS UNSUCCESSFUL AND THE TIP REMAINED LODGED IN THE ANATOMY. THE PATIENT IS SCHEDULED FOR BYPASS SURGERY, AT WHICH TIME THE TIP WILL BE REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED.