SENSOR

Description of Event or Problem

IT WAS REPORTED THAT DURING THE STENT PLACEMENT PROCEDURE, A SENSOR WIRE WAS USED. IT WAS FOUND THAT THE COATING WAS OBSERVED TO BE PEELED ON THE PROXIMAL HANDLE SIDE PORTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE ANALYSIS OF THE RETURNED DEVICE IDENTIFIED SLEEVE DETACHMENT.

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A0501 CAPTURES THE REPORTABLE INVESTIGATION RESULTS OF SLEEVE DETACHED. BLOCK D4, H4: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK H11: THE RETURNED SENSOR WIRE WAS ANALYZED, AND DURING THE INSPECTION, IT WAS OBSERVED THAT THE POLYTETRAFLUOROETHYLENE (PTFE) PEELED AT THE DISTAL SECTION OF THE DEVICE. ADDITIONALLY, THE SLEEVE WAS DETACHED FROM THE WIRE. ADDITIONALLY, THE SLEEVE WAS DETACHED FROM THE WIRE. A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENTS OF SLEEVE DETACHED/SEPARATED AND COATING PTFE PEELED/SHEARED WERE DEFINED IN THE RISK DOCUMENTATION. THESE EVENT TYPES HAVE BEEN ACCOUNTED DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFITS FOR THE PRODUCT. BASED ON THE INFORMATION AVAILABLE AND THE ANALYSIS PERFORMED, IT IS POSSIBLE TO CONCLUDE THAT THIS EVENT COULD BE CAUSED BY OPERATIONAL FACTORS. THE EXCESS OF FORCE APPLIED TO REMOVE THE WIRE PROBABLY CAUSED THE SLEEVE DETACHMENT. FURTHERMORE, THE EXCESSIVE FORCE APPLIED TO REMOVE THE WIRE OR USING A METAL NEEDLE OR CANNULA PROBABLY CAUSED PTFE TO PEEL. BASED ON THE RESULTS OF THE DEVICE EVALUATION, AN INVESTIGATION CONCLUSION CODE OF ADVERSE EVENT RELATED TO PROCEDURE WAS ASSIGNED TO THIS INVESTIGATION.