RHYTHMIA HDX MAPPING SYSTEM

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC IS UNABLE TO CONFIRM CAUSE OF THE REPORTED CLINICAL OBSERVATION OF "CATHETER CONNECTION BOX DAMAGED/DEFECTIVE" THAT LED TO THE PROCEDURE BEING CANCELLED/RESCHEDULED. DEVICE TECHNICAL ANALYSIS THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. DEVICE HISTORY RECORD REVIEW THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. LABELING REVIEW BASED ON THE INFORMATION PROVIDED, THERE IS NO EVIDENCE THAT THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE LABELLED INDICATIONS. RISK REVIEW A REVIEW OF THE RHYTHMIA HDX MAPPING SYSTEM HAZARD ANALYSIS WAS COMPLETED AND CONFIRMED THAT THE EVENT OF "CATHETER CONNECTION BOX DAMAGED/DEFECTIVE" WAS DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. INVESTIGATION CONCLUSION: BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF "CAUSE NOT ESTABLISHED". THE REASON FOR THE ALLEGED OBSERVATION COULD NOT BE DETERMINED.

Description of Event or Problem

IT WAS REPORTED THAT THE CONNECTION BOX CONNECTED TO THE POD WAS BROKEN, SUBSEQUENTLY THE PROCEDURE WAS CANCELLED. THE STATUS OF THE PATIENT SEDATION WHEN THE CANCELLATION OCCURRED IS UNKNOWN. DURING AN ABLATION PROCEDURE, A MAESTRO FORCE SENSING CONNECTION BOX WAS SELECTED FOR USE. UPON INSERTION, IT WAS NOTED THAT THE CONNECTION BOX WAS BROKEN. THE PROBLEM COULD NOT BE RESOLVED, AND THE PROCEDURE WAS SUBSEQUENTLY CANCELLED. THERE WERE NO PATIENT COMPLICATIONS. THIS IS BEING REPORTED FOR CANCELLATION OF THE PROCEDURE WITH SEDATION STATUS UNKNOWN.

Additional Manufacturer Narrative

IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT THE CONNECTION BOX CONNECTED TO THE POD WAS BROKEN, SUBSEQUENTLY THE PROCEDURE WAS CANCELLED. THE STATUS OF THE PATIENT SEDATION WHEN THE CANCELLATION OCCURRED IS UNKNOWN.DURING AN ABLATION PROCEDURE, A MAESTRO FORCE SENSING CONNECTION BOX WAS SELECTED FOR USE. UPON INSERTION, IT WAS NOTED THAT THE CONNECTION BOX WAS BROKEN. THE PROBLEM COULD NOT BE RESOLVED, AND THE PROCEDURE WAS SUBSEQUENTLY CANCELLED. THERE WERE NO PATIENT COMPLICATIONS. THE DEVICE IS NOT EXPECTED BE RETURNED FOR ANALYSIS. GOOD FAITH EFFORT (GFE) WAS SENT TO DETERMINE WHY THE DEVICE WILL NOT BE RETURNED. THIS IS BEING REPORTED FOR CANCELLATION OF THE PROCEDURE WITH SEDATION STATUS UNKNOWN.