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

Device Problem Defective Device (2588)

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

Event Date 06/26/2023

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 that pericardial effusion (pe) occurred.A left atrial appendage (laa) closure procedure was being performed.A versacross connect was utilized for transseptal puncture.A watchman was implanted.Post-procedure, a potential pericardial effusion surrounding the right ventricle was monitored for 10-15 minutes with no visible change.The patient was sent to recovery with an order for transesophageal echocardiogram (tee) for two (2) hours post-procedure.The tee showed the pe had grown in size, but the patient remained hemodynamically stable.Several physicians compared the tee images, and the patient was brought back to the catheterization laboratory four (4) hours post-procedure and a pericardiocentesis was performed.Approximately 1l of blood was drained.The pe appeared smaller but continued to slowly grow.Thirty (30) minutes into the pericardiocentesis, a surgeon was called, and a drain was placed; however, the pe showed no signs of stopping.Two (2) doses of kcentra and several rounds of fresh frozen plasma were administered but the pe continued to show no signs of stopping.The patient continued to remain hemodynamically stable.After two and a half (2.5) hours of attempting to slow the pe, the patient was transferred to the operating room.A small perforation was located in the anterior right ventricle wall which was surgically repaired.Bleed at the site stopped.The patient was extubated later that evening and doing well the next morning.The patient is fully recovered and discharged.The physician suspects the versacross connect system may have caused the perforation while attempting to manipulate it around the pacemaker wires prior to transseptal.It was confirmed that no pe was noted prior to the procedure, but also was not on the focus.It was also noted that a non-boston scientific j wire was maneuvered quickly across the patent when attempting to gain superior vena cava access.

• 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: 17344165
• MDR Text Key: 319277584
• Report Number: 2124215-2023-37015
• 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: 07/18/2023

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: 06/26/2023
• Initial Date FDA Received: 07/18/2023
• 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): Life Threatening; Required Intervention; Hospitalization; Other
• Patient Age: 71 YR
• Patient Sex: Female