VERSACROSS WIRE
Received Mar 23, 2026 · Event occurred Feb 11, 2026
Report MW5185635 · MDR key 24673075
Device
Generic name
Percutaneous Atrial Catheter Kit
Manufacturer
Boston Scientific CorporationProduct problems
- Patient Device Interaction Problem
Patient
NA · Unknown
- Low Blood Pressure/ Hypotension
- Cardiac Perforation
Narrative
Description of Event or Problem
PLEASE BE ADVISED THAT WHILE INVESTIGATING AN EVENT INVOLVING ONE OF OUR PRODUCTS, (B)(6). NOTED A POTENTIAL ADVERSE EVENT REGARDING A (B)(6). PRODUCT. DURING THE TRANSSEPTAL ACCESS WITH THE COMPETITOR FARADRIVE SHEATH AND VERSACROSS WIRE, THE POSTERIOR SIDE OF THE AORTA WAS PERFORATED. ON THE CARTO MAP, WHEN THE OCTARAY CATHETER WAS INSERTED, THE CATHETER WENT "STRAIGHT UP" INSTEAD OF APPEARING IN/NEAR THE VEINS. THE PATIENT'S BLOOD PRESSURE ALSO DROPPED. THE PATIENT'S BLOOD PRESSURE WAS THEN CHECKED VIA THE TRANSSEPTAL SHEATH- THE WAVEFORM TRACING LOOKED LIKE AN AORTIC MORPHOLOGY. SURGICAL TEAM WAS CALLED AND "OPEN HEART SURGERY" WAS PERFORMED IN THE EP PROCEDURE ROOM TO "STABILIZE THE PATIENT". THE PATIENT IS CURRENTLY STABLE. PATIENT CODE: 1914, 2513. DEVICE CODE: 4001. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REFERENCE REPORT MW5185634.