MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS CONNECT LAAC ACCESS SOLUTION; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Lot Number VMFB050523

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

Patient Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135)

Event Date 07/26/2023

Event Type  Death  

Event Description

It was reported that patient death occurred.A left atrial appendage closure procedure was being performed.A versacross connected was utilized with a watchman for transseptal puncture (tsp).The versacross connect and was were positioned into the right atrium.When advancing the versacross connect for tsp, the versacross rf wire perforated the aorta, causing fatal bleeding.Thus, a surgical intervention was attempted for aortic perforation repair, but it was unsuccessful, and the patient died on the table.

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that patient death occurred.A left atrial appendage closure procedure was being performed.A versacross connected was utilized with a watchman for transseptal puncture (tsp).The versacross connect and was were positioned into the right atrium.When advancing the versacross connect for tsp, the versacross rf wire perforated the aorta, causing fatal bleeding.Thus, a surgical intervention was attempted for aortic perforation repair, but it was unsuccessful, and the patient died on the table.It was further reported (29aug2023) that no pericardial effusion nor cardiac tamponade were noted.The tenting on the versacross wire was visible prior to the rf application (1-4 mm).There were no multiple attempts required to track up / drop down into position on septum before tsp was performed, and only one rf was applied.The versacross devices were not pushed very quickly, but they went straight into aorta.Both versacross rf wire and dilator crossed the septum.The patient had a very narrow lipominous septum.No issues with versacross devices were reported.

Manufacturer Narrative

Due to additional information received on 29aug2023, the field b5 (describe event or problem) was updated.And, to correction, the field b7 (other relevant history) was updated, thus the supplemental report will be filed.It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Type of Device: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BAYLIS MEDICAL COMPANY INC.; 5825 explorer drive; mississauga, on L4W 5 P6; CA L4W 5P6
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17566963
• MDR Text Key: 321371192
• Report Number: 2124215-2023-43688
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 00685447012573
• UDI-Public: 00685447012573
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/26/2023

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
• Device Operator: Health Professional
• Device Lot Number: VMFB050523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2023
• Initial Date FDA Received: 08/17/2023
• Supplement Dates Manufacturer Received: 08/29/2023
• Supplement Dates FDA Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Race: White