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

Lot Number VMFA290823

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

Patient Problems Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 01/18/2024

Event Type  Injury  

Event 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.

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
• 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: 18660042
• MDR Text Key: 334772159
• Report Number: 2124215-2024-06362
• Device Sequence Number: 1
• Product Code: DRE
• 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
• Report Date: 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
• Device Operator: Health Professional
• Device Lot Number: VMFA290823
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Race: White