MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS RF WIRE KIT; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, INCLUDING CONNECTOR

Model Number	VXW-35-230-P-WM
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While there was no patient injury report, baylis medical company inc.Has decided to report this event due to the 20-minute procedural delay.A dhr review was completed and the device fulfilled all requirements prior to release.
Event or Problem Description
A 20-minute procedural was reported for the versacross rf wire kit (containing the versacross rf wire and an rfp-100a connector cable (connector cable)) where the connector cable was not able to establish a connection when connected to the versacross rf wire and compatible rf generator during a left-atrial appendage closure (laac) procedure.While attempting to complete the transseptal puncture, the versacross wire was positioned on the septum and was then connected to the generator through the connector cable.However, the generator did not recognize that the device was connected.The connector cable was disconnected and reconnected, however, the generator still did not detect the device.The grounding pad that was connected to the generator was also swapped out and the generator was replaced with a second generator.However, the issue continued to persist.An nrg transseptal needle and connector cable (baylis medical company inc.) were opened and connected to the first generator and the transseptal puncture was successfully completed.While there was no patient injury reported, baylis medical company inc.Has decided to report this event due to the procedural delay.

• Brand Name: VERSACROSS RF WIRE KIT
• Common Device Name: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, INCLUDING CONNECTOR
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal, quebec H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BAYLIS MEDICAL COMPANY INC.; 2775 matheson blvd. east; mississauga, ontario L4W 4 P7; CA L4W 4P7
• Manufacturer Contact: meghal khakhar ; 5959 trans-canada highway; montreal, quebec H4T 1-A1 ; CA H4T 1A1
• MDR Report Key: 16117816
• Report Number: 3019751610-2023-00006
• Device Sequence Number: 20939303
• Product Code: DSA
• UDI-Device Identifier: 00685447011118
• UDI-Public: (01)00685447011118(17)250526(10)VXFB250522
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K023334
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/26/2025
• Device Model Number: VXW-35-230-P-WM
• Device Lot Number: VXFB250522
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown