REPROCESSING MISCELLANEOUS
Received Dec 31, 2025 · Event occurred Oct 21, 2025
Report 3032391-2025-00011 · MDR key 23933977
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Male
- Pleural Effusion
- Cardiac Perforation
- Asystole
- Intraoperative Cardiac Injury
- Pleural Effusion
- Cardiac Perforation
- Asystole
- Intraoperative Cardiac Injury
Narrative
Additional Manufacturer Narrative
ACCORDING TO THE CUSTOMER, DURING AN "ATRIAL FIBRILLATION PROCEDURE FOR PVI", THE CUSTOMER DEVELOPED A "PERICARDIAL EFFUSION" AFTER "TRANSSEPTAL PUNCTURE" WAS COMPLETED, AND THE MAPPING CATHETER WAS "PLACED IN THE LEFT ATRIUM AND STEERING WAS NOTED TO BE DIFFICULT". THE CUSTOMER REPORTED THAT AFTER THE PERICARDIAL EFFUSION WAS CONFIRMED WITH ULTRASOUND, A "PERICARDIOCENTESIS" WAS PERFORMED AND "APPROXIMATELY 1.5 LITERS" OF BLOOD WAS WITHDRAWN WITHIN AN HOUR. THE CUSTOMER REPORTED THAT THE PATIENT WENT INTO "ASYSTOLE" AND "THE EMERGENCY TEAM BEGAN WITH CPR, HOWEVER THE PATIENT DID NOT RECOVER AND EXPIRED IN THE CATH LAB". THE CUSTOMER REPORTED THAT THERE WERE "NO PRODUCT PERFORMANCE ISSUES WITH ANY PRODUCTS USED IN THIS CASE", BUT "THE CAUSE OF THE EFFUSION AND OF THE PATIENT'S DEATH ARE NOT CLEARLY KNOWN", AND "THE PERFORATION COULD HAVE POTENTIALLY OCCURRED AFTER TRANSSEPTAL PUNCTURE ON THE LEFT ATRIUM ROOF". AT THIS TIME THERE IS NO INFORMATION THAT INDICATES THAT THE PATIENT DEATH OCCURRED AS A RESULT OF A PRODUCT DEFECT OR PERFORMANCE ISSUE. NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED ISSUE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO DEATH, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
Description of Event or Problem
ACCORDING TO THE CUSTOMER, DURING AN "ATRIAL FIBRILLATION PROCEDURE FOR PVI", THE CUSTOMER DEVELOPED A "PERICARDIAL EFFUSION" AFTER "TRANSSEPTAL PUNCTURE" WAS COMPLETED, AND THE MAPPING CATHETER WAS "PLACED IN THE LEFT ATRIUM AND STEERING WAS NOTED TO BE DIFFICULT".