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	Pericardial Effusion (3271)
Date of Event	12/13/2022
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.
Event or Problem Description
A pericardial effusion was noted that lead to a procedural abortion where versacross large access transseptal dilator, versacross rf wire and agilis sheath (non-baylis device) were used.Transseptal was unsuccessful using the verscross large access transseptal dilator and versacross rf wire.Both transesophageal echocardiography (tee) and ice imaging were used but the physician was unable to view the dilator tent the septum.The physician decided to use the agilis sheath with the versacross rf wire.The physician had difficulty viewing the location of the catheter on the bicaval view.Transseptal was attempted three times however, the physician was unable to advance the devices into the septum.An effusion was noted via transesophageal echocardiography (tee) and on fluoroscopy.The patient's blood pressure dropped, and a pericardial tap was performed stabilizing the patients' blood pressure.Blood was re-infused into the patient.Once the fluid collection stopped, the physician decided to remove the drain.Patient was extubated, dressing was applied to subxyphoid area and the procedure was aborted.The patient was sent to recovery area.As a baylis medical device was reported to be among the devices used in the procedure, baylis medical has decided to submit this report for the versacross rf wire.

• 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 ; 5959 trans-canada highway; montreal, quebec H4T 1-A1 ; CA H4T 1A1
• MDR Report Key: 16154491
• Report Number: 3019751610-2023-00009
• Device Sequence Number: 15330235
• Product Code: DXF
• UDI-Device Identifier: 00685447003311
• UDI-Public: (01)00685447003311(17)250419(10)VXFD130422
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/12/2023

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: 04/19/2025
• Device Model Number: VXW-35-230-P
• Device Lot Number: VXFD130422
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 01/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown