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

Model Number VXS85-35-63-90-D0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 03/11/2022

Event Type  Injury  

Manufacturer Narrative

As baylis medical devices were reported to be among the devices used in the procedure, baylis medical has decided to submit this report.

Event Description

A case of an aortic perforation was reported during a heart procedure, where the baylis medical versacross rf wire (rf wire) and versacross transseptal sheath was used for the initial transseptal puncture.The physician experienced difficulty engaging the septum due to the patient's rotated and scoliotic anatomy.The physician attempted the transseptal puncture with the rf wire, and an aortic perforation with effusion was noted.The procedure was aborted and pericardiocentesis was performed.Follow-up requests revealed that the patient was recovering.As baylis medical devices were 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 rf wire with the report number 9710452-2022-00021.

• Brand Name: VERSACROSS TRANSSEPTAL SHEATH
• Type of Device: 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: 14056216
• MDR Text Key: 289504291
• Report Number: 9710452-2022-00022
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/08/2022

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
• Device Operator: Health Professional
• Device Model Number: VXS85-35-63-90-D0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2022
• Initial Date FDA Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention