MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS TRANSSEPTAL SHEATH; INTRODUCER, CATHETER

Model Number	VXS85-35-63-55-D1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemothorax (1896)
Date of Event	03/31/2022
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 on all devices in the lot was completed and all devices met relevant specifications prior to release; device malfunction is not suspected.
Event or Problem Description
During a left atrial appendage closure (laac) procedure, the versacross transseptal sheath and versacross rf wire (baylis medical company inc.) were used for the initial transseptal puncture of the procedure with no observed initial complications.After transseptal puncture, the watchman flx (boston scientific corp.) devices were used to complete the laac procedure.Upon post-procedure verification, the patient was noted to have a hemothorax.The hemothorax was drained and the patient was kept for observation.Follow-up requests reveled that the patient is doing well and is expected to recover.As the hemothroax was identified after completion of the closure procedure, there is no objective evidence to suggest that the baylis medical devices caused or contributed to the reported incident.However, as the baylis devices were 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 rf wire with report number.

• Brand Name: VERSACROSS TRANSSEPTAL SHEATH
• Common Device Name: INTRODUCER, CATHETER
• 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: 14249847
• Report Number: 9710452-2022-00024
• Device Sequence Number: 17254554
• Product Code: DYB
• UDI-Device Identifier: 00685447003595
• UDI-Public: (01)00685447003595(17)240302(10)VXFC220621
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K183655
• 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): 04/28/2022

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: 03/02/2024
• Device Model Number: VXS85-35-63-55-D1
• Device Lot Number: VXFC220621
• 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: 04/01/2022
• Initial Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2021
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown