VERSACROSS STEERABLE ACCESS SOLUTION
Received Apr 21, 2026 · Event occurred Mar 27, 2026
Report 2124215-2026-21434 · MDR key 24935261
Device
Generic name
Percutaneous Atrial Catheter Kit
Manufacturer
Boston Scientific CorporationModel number
VSTK0124Catalog number
VSTK0124
Lot number
0037264598
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Perforation
- Cardiac Perforation
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION ABLATION A RF WIRE WAS SELECTED FOR USE. IT IS BELIEVED THAT THE TRANSEPTAL WIRE PERFORATED IN OR AROUND THE LAA DURING EXCHANGE. A PERICARDIAL TAP WAS PERFORMED TO PULL BLOOD FROM THE SPACE AND STABILIZE THE PATIENT. THE PROCEDURE WAS CANCELLED AT THIS TIME AND THE PATIENT IS EXPECTED TO FULLY RECOVER.
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 DURING AN ATRIAL FIBRILLATION ABLATION A RF WIRE WAS SELECTED FOR USE. IT IS BELIEVED THAT THE TRANSEPTAL WIRE PERFORATED IN OR AROUND THE LAA DURING EXCHANGE. A PERICARDIAL TAP WAS PERFORMED TO PULL BLOOD FROM THE SPACE AND STABILIZE THE PATIENT. THE PROCEDURE WAS CANCELLED AT THIS TIME AND THE PATIENT IS EXPECTED TO FULLY RECOVER.
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.