VERSACROSS CONNECT LAAC ACCESS SOLUTION
Received Apr 10, 2026 · Event occurred Mar 17, 2026
Report 2124215-2026-19531 · MDR key 24842670
Device
Generic name
Percutaneous Atrial Catheter Kit
Manufacturer
Boston Scientific CorporationModel number
VXAK0107Catalog number
VXAK0107
Lot number
0038285553
Product problems
- Nonstandard Device
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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 PRIOR A PROCEDURE A VERSACROSS CONNECT WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTICED THAT THE TIP OF THE VERSACROSS DILATOR WAS DAMAGED, IT WAS PINCHED AND LOOKED ABNORMAL. THE ENTIRE SYSTEM WAS REPLACED. THE DEVICE IS NOT EXPECTED TO BE RETURNED AS IT WAS DISPOSED OF.