MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS ACCESS SOLUTION; INTRODUCER, CATHETER

Device Problem Difficult to Advance (2920)

Patient Problems Fistula (1862); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)

Event Date 01/11/2024

Event Type  Injury  

Event Description

It was reported that a versacross access solution was selected for use during a watchman procedure.An excessive bleeding from the groin was noted, thus the procedure was cancelled.The transeptal access was gained using versacross.There was a narrowing of the common femoral vein so additional pressure was applied to get the sheath to advance.Once advanced, it was possible to successfully get transeptal puncture.When pulling the versacross sheath out, an excessive bleeding from the groin was noted and additional pressure was applied to slow blood flow down.The watchman access sheath and versacross dilator were inserted but unsuccessful at advancing past the narrowing in the cfv (common femoral vein).The sheath was removed, and left groin access was discussed.During this time the, the patient was still bleeding excessively so the decision was made to terminate the procedure.The patient remained stable but after about 30 minutes hemostasis was still not obtained and a slight drop in blood pressure was noted.An interventional radiology was called, and the patient was transported for a diagnostic ct (computed tomography).It was determined patient had an undiagnosed av (arteriovenous) fistula which was the result of the excessive bleeding.The patient did receive blood, and no intervention beyond that was required.The patient was discharged, and it is doing well.The device is not expected to be returned for analysis (disposed).The patient was admitted to hospital beyond standard of care.In the physician's opinion, the versacross rf wire and the versacross dilator did not contribute to the ae.There was kinking at the distal portion of the versacross rf wire once removed where the narrowing of the vessel was.No other issues were noted.

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 ACCESS SOLUTION
• Type of Device: INTRODUCER, CATHETER
• 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: 18656210
• MDR Text Key: 334722514
• Report Number: 2124215-2024-04349
• Device Sequence Number: 1
• Product Code: DYB
• 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
• Report Date: 02/06/2024

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 02/06/2024
• 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 Sex: Male
• Patient Race: White