VERSACROSS CONNECT LAAC ACCESS SOLUTION
Received Jul 16, 2026 · Event occurred Jun 22, 2026
Report 2124215-2026-38360 · MDR key 25849837
Device
Generic name
Catheter, Septostomy
Manufacturer
Boston Scientific CorporationModel number
VXAK0107Catalog number
VXAK0107
Lot number
0039289313
Product problems
- Failure to Advance
Patient
78 YR · Female
- Hematoma
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED HEMATOMA AND THE PROCEDURE WAS CANCELLED. TRANSSEPTAL PUNCTURE WAS DIFFICULT, WITH MULTIPLE FAILED ATTEMPTS WITH A VERSACROSS CONNECT SHEATH, WAS THEN EXCHANGED FOR A VERSACROSS STEERABLE SHEATH AND TRANSSEPTAL PUNCTURE WAS SUCCESSFUL. WE WERE THEN AWARE OF AORTIC HEMATOMA FORMING AND DECISION WAS MADE TO ABORT WATCHMAN PROCEDURE AND REVERSE ANTICOAGULATION. 2 27MM DEVICES WERE OPENED (1 CONTAMINATED) BUT WERE NEVER PUT INTO THE PATIENT. AS INTERVENTIONS REVERSED ANTICOAGULATION AND MONITORED PATIENT WERE DONE. THE PATIENT WAS HOSPITALIZED AND HAS NOT BEEN DISCHARGED YET. PHYSICIAN FELT THE AORTIC HEMATOMA WAS CAUSED BY MULTIPLE FAILED TRANSEPTAL PUNCTURE ATTEMPTS. PATIENT WAS STABLE HEMODYNAMICALLY FOR THE ENTIRE PROCEDURE. PATIENT STAYED OVERNIGHT IN INTENSE CARE UNIT AND RECEIVED A COMPUTED TOMOGRAPHY (CT) SCAN. UPON REVIEW OF CT SCAN PHYSICIANS SAID THE HEMATOMA HAD RESOLVED. PATIENT REMAINED STABLE AND AORTIC HEMATOMA HAD RESOLVED SAME DAY.