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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Date 08/04/2023

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 a versacross connect system was selected for use during a watchman case - laac.During the procedure, the physician accessed arterial groin with a non-boston scientific 12f dilator to pre-dilate the vein prior to use versacross access system.Thus, the versacross connect (dilator, versacross rf wire and the was sheath) were advanced into the groin and into the superior vena cava.A transseptal drop down was attempted, once physician noted bleeding at access site in the groin, around the versacross connect system so they removed the whole system.Thus, a non-boston scientific device (a gore 16f sheath) was used, and hence the same versacross connect system was reinserted.Bleeding around the non boston scientific sheath continued, and a hematoma was noted, therefore the physician aborted the case, and protamine was given to the patient.The access sites were closed and manual pressure was applied until bleeding stabilized.The patient was admitted to the icu for observation and discharged next day due to fully recovery.The physician believes that the access at the groin was done poorly from the start and the versacross access system did not contribute to the issue.The device is not expected to be returned for analysis (disposed).

• 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: 17628700
• MDR Text Key: 322024276
• Report Number: 2124215-2023-45234
• 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: 08/25/2023

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: 08/04/2023
• Initial Date FDA Received: 08/25/2023
• 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; Other; Required Intervention
• Patient Age: 85 YR