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

Lot Number	VMFA290823
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	01/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a versacross connect access solution was selected for use during a watchman procedure.A perforation and a pericardial effusion were noted.The procedure was cancelled.The physician noted that there was a small posterior localized pericardial effusion observed via intra-cardiac echocardiography (ice) prior to procedure.There wasn't any difficulty in crossing the septum.The watchman was advanced into the left atrium appendage after transeptal puncture.During the contrast injection of appendage, the physician noted a perforation of the left atrial appendage with a circumferential pericardial effusion.The versacross rf wire was still in the left atrium when the performation was noticed.Then, the physician decided to abort the procedure.Pericardiocentesis was performed to treat the effusion.There were no further patient complications reported.The patient recovered and it was discharged.The device is not expected to be returned for analysis.It was reported that it is possible that the perforation had happened along with watchman double curve sheath and versacross connect dilator.Possibly happened after removal of dilator and positioning of sheath into appendage, and it was not possible to exclude the contribution from versacross rf wire.The physician's feels like the perforation could have been caused by the sheath when trying to cannulate the appendage for the contrast injection.Ice imaging was not very good and did not quite show the distal appendage.It is possible the sheath was further in the appendage than we thought.No issues with the versacross devices were reported.During transseptal, the septum was clearly visible and there was a normal amount of tenting when rf was applied.
Additional 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.

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Common Device Name: 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: 18660042
• Report Number: 2124215-2024-06362
• Device Sequence Number: 7297956
• Product Code: DRE
• UDI-Device Identifier: 00685447012566
• UDI-Public: 00685447012566
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/07/2024

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: 05/28/2026
• Device Lot Number: VMFA290823
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Race: White