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	08/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As a baylis medical device was reported to be among the devices used in the procedure, baylis medical has decided to submit this report.A dhr review was completed for the lot in question and all the devices fulfilled all requirements prior to release.
Event or Problem Description
A case of aortic perforation leading to procedural abortion was reported where the versacross transseptal sheath and versacross rf wire were used for transseptal puncture.Transseptal puncture was completed successfully twice.However, the location of the puncture was not optimal for implantation of the watchman device.On the third attempt, the versacross rf wire and versacross transspetal sheath crossed the septum successfully and advanced into the left atrium where a perforation occurred.An effusion was also noted using transesophageal echocardiography and was treated with pericardiocentesis.The physician consulted surgery and the procedure was aborted.As a baylis medical device was reported to be among the devices used in the procedure, baylis medical has decided to submit this report.A separate problem report has been submitted for the versacross transseptal sheath with the report number 3019751610-2022-00030.

• 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: 15337611
• Report Number: 3019751610-2022-00029
• Device Sequence Number: 6485798
• Product Code: DXF
• UDI-Device Identifier: 00685447003298
• UDI-Public: (01)00685447003298(17)250106(10)VXFE221221
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 09/01/2022

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 Model Number: VXW-35-180-P
• Device Lot Number: VXFE221221
• 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: 08/08/2022
• Initial Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2022
• 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: Other; Required Intervention
• Patient Sex: Unknown