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

Lot Number	VLFA230423
Medical Device Problem Codes	Difficult to Advance (2920); Positioning Problem (3009)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Perforation (2001); Pericardial Effusion (3271)
Date of Event	09/07/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
"**udi related data quality updates only** this report is being filed as a correction in response to an fda request for the complete the unique identifier (udi) #." 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 or Problem 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.

• Brand Name: VERSACROSS LARGE ACCESS SOLUTION
• Common Device Name: 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: 17879185
• Report Number: 2124215-2023-54611
• Device Sequence Number: 15317572
• Product Code: DRE
• UDI-Device Identifier: 00685447012481
• UDI-Public: (01)00685447012481(17)20260228(10)VLFA230423
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K201288
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Lot Number: VLFA230423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2023
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female