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); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 09/15/2023

Event Type  Injury  

Event Description

It was reported a pericardial effusion with cardiac tamponade occurred.During a watchman left atrial appendage closure (laac) procedure, a versacross connect kit was selected for use.The transseptal puncture was performed successfully.The imaging physician (transesophageal echocardiogram (tee)) noted a pericardial effusion with tamponade was identified at the left atrium.The patient's vitals were monitored and the watchman device implantation was performed.After implantation of the closure device, a pericardiocentesis was performed.The patient was stabilized however hospitalized beyond standard care.The device is not expected to be returned for analysis.

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.

Manufacturer Narrative

Correction to the mdr: initial.Mdr in block(s) h6 patient codes.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 (pe) with cardiac tamponade occurred.During a watchman left atrial appendage closure (laac) procedure, an unknown versacross kit was selected for use.The transseptal puncture was performed successfully.The imaging physician (transesophageal echocardiogram (tee)) noted a pericardial effusion with tamponade was identified at the left atrium.The patient's vitals were monitored and the watchman device implantation was performed.After implantation of the closure device, a pericardiocentesis was performed.The patient was stabilized however hospitalized beyond standard care.The device is not expected to be returned for analysis.It was further confirmed, the versacross kit information is unknown.Both perforation and cardiac tamponade occurred.Pericardial effusion was not noted prior to the procedure.No difficulties noted with patient anatomy or attempts tracking up/down to position on septum.Transseptal puncture was completed prior to pe and was only attempted once.Pe may occurred in left ventricular (lv) or left atrium and was noted post transseptal puncture during pig tail catheter exchange.

• 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: 17928205
• MDR Text Key: 325564142
• Report Number: 2124215-2023-56121
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183655
• 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,Followup
• Report Date: 11/07/2023
• 2 Devices were Involved in the Event: 1 2

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: 09/15/2023
• Initial Date FDA Received: 10/12/2023
• Supplement Dates Manufacturer Received: 10/30/2023
• Supplement Dates FDA Received: 11/07/2023
• 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: 82 YR
• Patient Sex: Male