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

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 10/17/2023

Event Type  Injury  

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 a pericardial effusion and likely a tamponade occurred.The procedure was cancelled.During the watchman procedure to treat atrial fibrillation (a fib) procedure, a versacross connect kit was selected for use.The transseptal puncture was performed however the appendage access was not optimal with two partial recaptures of the watchman device.The physician then re-assessed for new transseptal puncture site more towards the anterior.The patient anatomy was posing challenges and it was difficult to cross with the radio frequency wire but transseptal puncture was performed successfully.Right after (about one hour and fifteen minutes into the procedure after re-crossing the septum), an effusion was noted and patients blood pressure dropped.A thoracentesis was performed and patient recovered.It was decided to abort the procedure.The device is not expected to be returned for analysis.Multiple attempts were made to across the septum for the second time.The third attempt was successful and effusion was followed.The patient recovered and was discharged home next day.The physician admits it was challenging and was also 'practicing with ice' so had a non-boston scientific 'large boar sheath' in the left side.The second attempt transseptal puncture was performed with same versacross kit and no issues noted during transseptal puncture.The patient had thick septum.In the physicians opinion, the device did not contribute to the adverse event.

• 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, qc 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: 18094324
• MDR Text Key: 327657912
• Report Number: 2124215-2023-62248
• 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: 11/08/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2023
• Initial Date FDA Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 83 YR
• Patient Sex: Female