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 Perforation (2001); Pericardial Effusion (3271)

Event Date 07/21/2023

Event Type  Injury  

Event Description

It was reported that a pericardial effusion occurred post procedure.It was reported that a versacross connect was selected for use during a watchman left atrium appendage closure, which was completed, with no issues noted during transseptal (it was inferior and posterior).Several hours post procedure, prior to discharge the patient, a pericardial effusion was noted.Thus, a pericardiocentesis was performed.The patient was admitted to hospital beyond standard of care and it has been discarded on (b)(6) 2023.The device is not expected to be returned for analysis.No pe was noted prior to the procedure.No other issues were noted in regards to the transseptal.There is no reason to suspect that they were attributed to versacross connect devices.There was a wire sheath exchange done in the appendage where the versacross wire was briefly exposed out of the pigtail catheter and not fully deployed in its safe loop.This is when boston sales rep believes to be the most likely time for the perforation to have occurred.The physician could not determine which time the perforation actually occurred.The most remarkable part of the procedure was the difficulty getting the pigtail catheter to advance into the appendage.No confirmation of that on the echo or fluoroscopic findings.

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: 17701957
• MDR Text Key: 322879015
• Report Number: 2124215-2023-43631
• 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: 09/07/2023

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: 07/21/2023
• Initial Date FDA Received: 09/07/2023
• 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; Hospitalization
• Patient Age: 89 YR
• Patient Sex: Male