MalfunctionOFK

VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE

Received Nov 18, 2025 · Event occurred Sep 29, 2025

Report 23581148 · MDR key 23581148

Device

Generic name

Percutaneous Atrial Catheter Kit

Manufacturer

Baylis Medical Company, Inc.

Model number

VXAK0041

Catalog number

Lot number

37006895

Product problems

Break

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

THE STEERING MECHANISM OF THE VERSACROSS DILATOR BROKE. THE DILATOR WAS REMOVED AND REPLACED WITH NO REPORTED HARM TO THE PATIENT. MANUFACTURER RESPONSE FOR TRANSSEPTAL ACCESS DEVICE, 1 X VERSACROSS CONNECT TRANSSEPTAL DILATOR; 1 X VERSACROSS RF WIRE (PER SITE REPORTER).