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

Model Number	VXW-35-230-P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	06/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As baylis medical devices were reported to be among the devices used in the procedure, baylis medical has decided to submit this report.Device malfunction is not suspected.A dhr review has been completed for the lot in question and all devices in the lot met relevant requirements prior to release.
Event or Problem Description
A case of an aortic perforation leading to a procedural abortion during a left atrial appendage closure (laac) procedure was reported where the baylis medical versacross rf wire (rf wire) was used for the initial transseptal puncture of the procedure.The patient's atrial septum was noted to be hyper elastic on transesophageal echocardiogram (tee).The rf wire was positioned on the septum.The rf wire crossed the septum and was noted to be advanced in the aorta on tee.The rf wire was retracted into the right atrium.A pigtail catheter was introduced into the aorta.Contrast was administered, and a puncture to the aorta was confirmed.The laac procedure was aborted.The patient was stable and underwent computed tomography imaging.Minimal pericardial effusion was noted.The aortic perforation was reported to heal as the patient continued to remain in stable condition 12 hours later.As a baylis medical device was reported to be among the devices used in the procedure, baylis medical has decided to submit this report.

• 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: 14957870
• Report Number: 3019751610-2022-00011
• Device Sequence Number: 6953245
• Product Code: DXF
• UDI-Device Identifier: 00685447003311
• UDI-Public: (01)00685447003311(17)250119(10)VXFC180122
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 07/08/2022

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: 01/19/2025
• Device Model Number: VXW-35-230-P
• Device Lot Number: VXFC180122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization
• Patient Sex: Unknown