VERSACROSS CONNECT LAAC ACCESS SOLUTION
Received Jun 24, 2026 · Event occurred Jun 3, 2026
Report 2124215-2026-33688 · MDR key 25612091
Device
Generic name
Catheter, Septostomy
Manufacturer
Boston Scientific CorporationModel number
VXAK0107Catalog number
VXAK0107
Lot number
0038311643
Product problems
- Difficult to Advance
Patient
NA · Unknown
- Low Blood Pressure/ Hypotension
- Pericardial Effusion
Narrative
Description of Event or Problem
IT WAS REPORTED A PERICARDIAL EFFUSION (PE), AND HYPOTENSION OCCURRED. IT WAS REPORTED THAT FOR A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE SECONDARY TO ATRIAL FIBRILLATION A VERSACROSS CONNECT WAS SELECTED FOR USE. THE PATIENT WAS INTUBATED AND PREPPED FOR THE LAAC PROCEDURE. WHEN THE VERSACROSS WIRE WAS BEING BROUGHT UP INTO THE SUPERIOR VENA CAVA (SVC), THE FELLOW WHO WAS ATTEMPTING THE TRANSEPTAL PUNCTURE (TSP) AND HAD TO ATTEMPT A FEW RUNS TO GET THE WIRE INTO THE SVC. THERE IS AN ASSUMPTION BY THE IMPLANTING TEAM THAT IT MAY HAVE BEEN AT THIS STAGE THAT THE WIRE MAY HAVE SLIPPED THROUGH A PATENT FORAMEN OVALE (PFO) AND SLIPPED INTO THE LEFT ATRIAL APPENDAGE (LAA). THERE SEEMS TO BE NO OTHER MOMENT DURING THE PROCEDURE THAT THE TEAM FEELS THEY CAN ATTRIBUTE TOWARDS THE CAUSING EVENT. PRE IMAGES SHOWED A TRIVIAL PE AROUND THE LAA. AFTER THE TSP, AN ANGIOGRAM WAS DONE OF THE APPENDAGE AND THERE DID NOT SEEM TO BE ANYTHING OUT OF THE ORDINARY. WHEN THE WATCHMAN 27MM DEVICE WAS BROUGHT INTO THE APPENDAGE, THE ECHO OPERATOR MENTIONED THAT THERE MAY BE AN EFFUSION, AT THE SAME TIME THE FELLOW HAD UNSHEATHED THE DEVICE, AND IT SEEMED VISUALLY TO BE APPROPRIATELY PLACED AT THE OSTIUM. AT THIS TIME, THE STAFF WHO IMPLANTED PERFORMED A TUG TO ENSURE DEVICE STABILITY, THE DECISION WAS MADE TO QUICKLY SWEEP WITH THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) TO RULE OUT A LEAK AND THEN TO RELEASE THE DEVICE. ONCE IT WAS OBSERVED NOT TO HAVE A LEAK, THE DEVICE WAS RELEASED, AND POST RELEASE MEASUREMENTS SHOW THE DEVICE TO BE AT THE OSTIUM, A COMPRESSION OF BETWEEN 10-15% AND NO LEAK SEEN IN ANY ANGLES. PROTAMINE WAS ADMINISTERED AS PER A STAFF MEMBER, AND IT TOOK ABOUT AN ADDITIONAL 40 MINUTES OF TIME WHERE THE TEAM KEPT THE PE UNDER OBSERVATION AND NOTED THAT IT DID NOT SEEM TO BE GROWING ANY LARGER AND MAY EVEN BE SHOWING SIGNS OF CLOTTING OFF. THE PE WAS CONSIDERED TO BE TOO SMALL TO TAP AT THE TIME IT WAS BEING OBSERVED. THE PATIENT WILL BE ADMITTED TO THE CARDIAC CARE UNIT AND OBSERVED. THERE DOES NOT SEEM TO BE AN EXPECTATION THAT THE PE WILL GROW LARGER AND NEED A TAP. MEDICATIONS WERE ADMINISTERED TO MAINTAIN BLOOD PRESSURE. A BEDSIDE ECHO WAS DONE, AND THE PE WAS KEPT UNDER OBSERVATION. NO DEVICE ISSUES WERE REPORTED. IT WAS FURTHER REPORTED THAT THE PATIENT IS EXPECTED TO RECOVER WELL AND BE DISCHARGED. NO PRE PROCEDURE PE WAS NOTED. THERE WERE NO DIFFICULTIES DISCOVERED WITH POSITIONING THE SHEATH OR DILATOR FOR TSP, THE PROCEDURE OVERALL SEEMED TO GO AS PLANNED. AS PER THE PHYSICIANS, THERE WAS SOME TROUBLE GETTING THE WIRE INTO THE SVC, BUT THEY DO NOT BELIEVE IT WAS DEVICE RELATED. THE TSP WAS ON ITS OWN NORMAL WITH NO ISSUES. THE ONLY TROUBLE HAD INITIALLY BEEN GETTING THE COIL UP INTO THE SVC. THE TRANSSEPTAL PUNCTURE WAS AN INFERIOR AND POSTERIOR PUNCTURE. DURING THE TSP THERE WAS NO OBVIOUS USE OF EXCESSIVE FORCE, BUT THERE MAY HAVE BEEN SOME ADDITIONAL FORCE WHEN TRYING TO BRING THE COIL OF THE WIRE INTO THE SVC.