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

Device Problem Difficult to Advance (2920)

Patient Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135)

Event Date 12/11/2023

Event Type  Injury  

Event Description

It was reported that a versacross access solution was selected for use.During the procedure, the physician got access on the patient.While putting up the versacross rf wire and the connect system, it was not possible to advance the wire.It was noted on contrast imaging that the femoral vein appeared to have little leaks.The physician suspected that the was sheath scratched the femoral vein during insertion and/or advancement.The physician left the was sheath in placed and accessed the opposite side of the patient to place a stent on the femoral vein leaks.The was was removed, and a non-bsc introducer sheath was advanced along with a new was.The patient remained stable, and the procedure was completed successfully.The device is not expected to be returned for analysis.The patient was admitted to hospital beyond standard of care.It was further reported that in the physician's opinion, the versacross dilator and the versacross rf wire did not contribute to the scratch in the femoral vein.It was confirmed the product used (versacross connect).No noticeable damage to the catheter or sheath that could have caused or contributed.It was tried to use straight mechanical guidewire and also had difficulty.A difficult vein anatomy was noted during the case.The patient was discharged.Case was completed successfully.No other issues were reported.

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: 18510258
• MDR Text Key: 332871534
• Report Number: 2124215-2023-74005
• 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: 01/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2024
• 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
• Date Manufacturer Received: 12/27/2023
• 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): Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male