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

Lot Number VMFA310822

Device Problem Difficult to Advance (2920)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 11/14/2022

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 that a cardiac perforation and pericardial effusion occurred.A left atrial appendage (laa) closure procedure was attempted using a 35mm watchman flx laa closure device with delivery system (wds) and a watchman fxd curve access system, double (was).Transeptal puncture was performed with a watchman double fxd curve sheath, a versacross connect laac access solution dilator, and a versacross connect laac access solution radiofrequency (rf) wire.After the tsp was performed, the rf wire was removed and the was moved backwards into the right atrium.A second tsp was performed and deployment of a 35mm closure device was attempted.The physician determined the trajectory for closure device implantation was not ideal with the current position of the tsp.A third tsp was performed and the was exchanged for a watchman fxd curve access system, single.Deployment of a 35mm closure device was again attempted; following this deployment attempt a pericardial effusion was discovered.The laa closure procedure was aborted upon the discovery of the pericardial effusion.The patient remained hemodynamically stable for 30 minutes before they became hypotensive.A pericardiocentesis was performed but the patient did not stabilize.The patient was transferred to surgery where a perforation was found on the posterior wall of the right atrium.The perforation was surgically repaired and the laa was ligated.Two days post index procedure the patient had fully recovered and was discharged.

• 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: 17624625
• MDR Text Key: 321964845
• Report Number: 2124215-2023-45824
• 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
• Report Date: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: VMFA310822
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention