MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACRISS CONNECT TRANSSEPTAL DILATOR; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	VXA12-85-35-WM-D1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	09/13/2022
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 a baylis medical device was reported to be among the devices used in the procedure, baylis medical has decided to submit this report.Dhr review was completed for the lot in question and the devices fulfilled all requirements prior to release.
Event or Problem Description
A case of thrombus formation was reported during an left atrial appendage closure procedure where the versacross connect transseptal dilator (vxa) was used for the transseptal puncture.While positioning the vxa and watchman access sheath (boston scientific) on the septum, a thrombus formation at the distal end of the vxa was noted on transesophageal echocardiogram (tee) imaging.The devices were removed and flushed, no thrombus was noted on any device or on imaging.The devices were reinserted and the transeptal puncture and subsequent laac procedure was successfully completed with no patient harm.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: VERSACRISS CONNECT TRANSSEPTAL DILATOR
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• 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: 15581927
• Report Number: 3019751610-2022-00036
• Device Sequence Number: 6184566
• Product Code: DRE
• UDI-Device Identifier: 00685447010531
• UDI-Public: (01)00685447010531(17)241126(10)VMFB250322
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K220414
• 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): 10/11/2022

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: 11/26/2024
• Device Model Number: VXA12-85-35-WM-D1
• Device Lot Number: VMFB250322
• 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: 09/13/2022
• Initial Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2022
• 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
• Patient Sex: Unknown