VIKING
Received Jul 22, 2025 · Event occurred Jun 23, 2025
Report 2124215-2025-48710 · MDR key 22564782
Device
Generic name
Intracardiac Electrode
Manufacturer
Boston Scientific CorporationProduct problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Low Blood Pressure/ Hypotension
- Pericardial Effusion
- Low Blood Pressure/ Hypotension
- Pericardial Effusion
Narrative
Description of Event or Problem
IT WAS REPORTED THAT PRIOR TO ABLATION, THE PATIENT EXPERIENCED HYPOTENSION AND EFFUSION. DURING AN ABLATION PROCEDURE, A VIKING ELECTRODE CATHETER WAS SELECTED FOR USE. PRIOR TO ABLATION, THE PATIENT BECAME HYPOTENSIVE AFTER COUGHING AND MOVING ON THE TABLE. THE PERICARDIAL SPACE WAS CHECKED, AND THERE WAS AN EFFUSION. THERE WAS NO ABLATION PERFORMED. NO FURTHER INFORMATION WAS PROVIDED. THE DEVICE PERFORMED AS EXPECTED DURING THE PROCEDURE AND THERE WERE NO REPORTS OF ANY PERFORMANCE CONCERNS. THERE IS NO INDICATION IF THE DEVICE WILL BE RETURNED. ADDITIONALLY, THIS EVENT WAS REPORTED VIA MEDWATCH - MW5172172.
Additional Manufacturer Narrative
DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. GOOD FAITH EFFORTS TO OBTAIN THE INFORMATION ARE IN PROGRESS. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) AND OTHER SPECIFIC PRODUCT INFORMATION AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE FILED IF THE INFORMATION IS RECEIVED. 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.