MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS RF WIRE; CATHETER, SEPTOSTOMY

Model Number	VXW-35-180-P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	02/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A case of aortic perforation leading to a procedural abortion was reported during a cryoablation atrial fibrillation procedure, where the versacross rf wire was used to attempt transseptal puncture.Due to complex patient anatomy, the physician attempted a more superior transseptal approach, and while advancing the rf wire, the physician noticed an artifact and maneuvered an ice catheter to investigate.Upon investigation, the rf wire was observed to be in the aorta.The physician immediately requested a surgical consult, after which the rf wire was removed from the aorta without further complications.The procedure was aborted and the patient was admitted to the icu for overnight observation where they were later sent home.
Additional Manufacturer Narrative
A dhr review was completed for the lot in question, and it was confirmed that all devices met relevant requirements prior to release.

• Brand Name: VERSACROSS RF WIRE
• Common Device Name: CATHETER, SEPTOSTOMY
• 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 ; 2775 matheson blvd. east; mississauga, ontario L4W 4-P7 ; CA L4W 4P7
• MDR Report Key: 13739460
• Report Number: 9710452-2022-00012
• Device Sequence Number: 4762358
• Product Code: DXF
• UDI-Device Identifier: 00685447003298
• UDI-Public: (01)00685447003298(17)240928(10)VXFH170921
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K150709
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2024
• Device Model Number: VXW-35-180-P
• Device Lot Number: VXFH170921
• 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: 02/14/2022
• Supplement Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 03/11/2022
• Supplement Report FDA Received Date: 03/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown