N/A

Additional Manufacturer Narrative

INNOVATIVE HEALTH RECEIVED A COMPLAINT REPORT ON 08 JUNE 2021, REGARDING AN ADVISOR HD (D-AVHD-DF16), UNKNOWN SERIAL NUMBER. THE REPORTING FACILITY WAS (B)(6). THE EVENT REPORTED WAS A PATIENT THAT HAD DEVELOPED A PNEUMOTHORAX IN A PROCEDURE THAT INCLUDED THE USE OF A REPROCESSED ADVISOR HD GRID MAPPING CATHETER. INNOVATIVE HEALTH CONTACTED THE FACILITY ON THE FOLLOWING DAYS: 09-JUN-2021, 10-JUN-2021, AND AGAIN ON 14-JUN-2021. A MEETING WITH THE CUSTOMER TOOK PLACE ON (B)(6) 2021. DURING THIS MEETING, IT WAS CLARIFIED THAT THE REPORTED EVENT WAS A HEMOTHORAX THAT PRESENTED APPROXIMATELY 2 HOURS AFTER THE PROCEDURE WAS CONCLUDED. IT WAS COMMUNICATED ALSO THAT THE PRODUCT WAS NOT KEPT AS THE CASE HAD BEEN COMPLETED WITH NO NOTED ISSUES. INNOVATIVE HEALTH CONTACTED THE HOSPITAL AGAIN ON 23-JUN-2021 AND ON 29-JUN-2021 IN AN EFFORT TO OBTAIN FURTHER DETAILS ABOUT THE CASE, HOWEVER NO ADDITIONAL DETAILS WERE PROVIDED. CONCLUSION: THE REPROCESSED ADVISOR HD GRID MAPPING CATHETER IS INDICATED FOR MULTIPLE ELECTRODE ELECTROPHYSIOLOGICAL MAPPING OF CARDIAC STRUCTURES IN THE HEART. THIS CATHETER IS INTENDED TO OBTAIN ELECTROGRAMS IN THE ATRIAL AND VENTRICULAR REGIONS OF THE HEART. DURING THE CALL WITH THE HOSPITAL ON (B)(6) 2021, IT WAS CONFIRMED THAT NO COMPLICATIONS WERE NOTED DURING THE CASE. THE NOTED COMPLICATION (HEMOTHORAX) OCCURRED ABOUT 2 HOURS AFTER THE CASE WAS COMPLETED. BASED ON THE INFORMATION INNOVATIVE HEALTH WAS ABLE TO OBTAIN ON THIS CASE AND NOT BEING ABLE TO COMPLETE FURTHER INVESTIGATION ON THE SUBJECT DEVICE (DEVICE DISCARDED AFTER THE PROCEDURE), INNOVATIVE HEALTH CANNOT CONFIRM THERE WERE PERFORMANCE ISSUES WITH THE REPROCESSED ADVISOR HD GRID MAPPING CATHETER.

Description of Event or Problem

INNOVATIVE HEALTH RECEIVED A COMPLAINT REPORT REGARDING AN ADVISOR HD (D-AVHD-DF16), UNKNOWN SERIAL NUMBER. PER THE REPORT RECEIVED, APPROXIMATELY 2 HOURS POST PROCEDURE, THE PATIENT PRESENTED A HEMOTHORAX (NOTE: THIS WAS INITIALLY REPORTED AS A PNEUMOTHORAX; HOWEVER, A MEETING WITH THE CUSTOMER ON (B)(6) 2021 CLARIFIED THE INJURY). NO DEVICE FAILURES WERE REPORTED DURING THE PROCEDURE. THE DEVICE WAS DISCARDED AND IS UNAVAILABLE TO BE RETURNED.