MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS ACCESS SOLUTION; CATHETER, SEPTOSTOMY

Model Number	VXSK0031
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no reasonable evidence to suggest that the baylis medical devices caused or contributed to the reported incident.However, as baylis medical devices were reported to be among the devices used in the procedure, baylis medical has decided to submit this report.A dhr review was completed for all the devices in the lot and all devices meet relevant specifications prior to release.
Event or Problem Description
During a cardiology procedure, after the transseptal puncture was completed with the versacross rf wire (vxw) from the versacross access solution kit, a piece of tissue debris was noted to be adhered to the vxw on intracardiac echocardiography.The debris was aspirated, and the procedure continued.There is no reasonable evidence to suggest that the baylis medical devices caused or contributed to the reported incident.However, as baylis medical devices were reported to be among the devices used in the procedure, baylis medical has decided to submit this report.

• Brand Name: VERSACROSS ACCESS SOLUTION
• 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 ; 5959 trans-canada highway; montreal, quebec H4T 1-A1 ; CA H4T 1A1
• MDR Report Key: 16117815
• Report Number: 3019751610-2023-00004
• Device Sequence Number: 6961312
• Product Code: DXF
• UDI-Device Identifier: 00685447011828
• UDI-Public: (01)00685447011828(17)241210(10)VXFC170822
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 01/06/2023

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: 12/10/2024
• Device Model Number: VXSK0031
• Device Lot Number: VXFC170822
• 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: 12/08/2022
• Initial Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown