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

Lot Number VLFA230423

Device Problems Difficult to Advance (2920); Positioning Problem (3009)

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation (2001); Pericardial Effusion (3271)

Event Date 09/07/2023

Event Type  Injury  

Event Description

It was reported a pericardial effusion occurred during a left atrial appendage closure (laac) procedure.A versacross large access system kit was selected for use.The physician was experiencing difficulty crossing the intra atrial septum and even after multiple attempts, the ideal puncture site could not be achieved.While attempting to secure the transseptal puncture site, a pericardial effusion was noted on transesophageal echocardiogram (tee).Hence the procedure was cancelled.Pericardial tap was performed however the effusion continued to grow very quick and bleed.The patient was then sent to the operating room for the cardiovascular surgery.As per the surgeon, the patient had a small tear at the juncture of the right atrium/inferior vena cava (ivc).The device is not expected to be returned for analysis.It was further advised, there was a perforation, site is unknown at the time of procedure however substantial enough fluid to cause a temporary drop in blood pressure.There was no pe noted on tee prior to the procedure.There was difficulty locating the correct tsp site which required additional maneuvering in the right atrium.No difficult patient anatomy noted.At least 3-4 attempts required to track up / drop down into position on septum before tsp.When pe was noted, the rf was never applied hence no tsp achieved.It is not believed that the versacross wire malfunctioned during the procedure.Act was therapeutic during the procedure.Patient has been discharged.It was further advised, the rf wire was not exposed outside of dilator during tsp attempts and no manual force applied.The perforation cause is unknown.Physician believes that the patient was frail and her tissue was quite delicate.

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 LARGE 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: 17879185
• MDR Text Key: 325021005
• Report Number: 2124215-2023-54611
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 00685447012481
• UDI-Public: 00685447012481
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K201288
• 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: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: VLFA230423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female