CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
Received Mar 13, 2024 · Event occurred Mar 4, 2024
Report 2124215-2024-14459 · MDR key 18895278
Device
Generic name
Cable, Transducer And Electrode, Patient, (including Connector)
Manufacturer
Boston Scientific CorporationProduct problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Pericardial Effusion
- Pericardial Effusion
Narrative
Additional Manufacturer Narrative
THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT AFTER THE COMPLETION OF ATRIAL FIBRILLATION ABLATION REDO PROCEDURE USING AN UNKNOWN BOSTON SCIENTIFIC (BSC) ELECTROPHYSIOLOGY DEVICE, THE PATIENT EXPERIENCED EPICARDIAL BLEEDING DURING AN ECHOCARDIOGRAM. DUE TO THE AMOUNT OF FLUID ACCUMULATED, A PERICARDIOCENTESIS WAS REQUIRED. THE PATIENT WAS STABLE FROM A HEMODYNAMIC PERSPECTIVE. AFTER THE PERICARDIOCENTESIS, THE PATIENT RECOVERED. NO PRODUCT ISSUES WERE NOTED. THE ORIGINAL DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT IS UNKNOWN IF DEVICE WILL BE RETURNED FOR ANALYSIS.