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

Lot Number VMFI280623

Device Problems Difficult to Remove (1528); Device-Device Incompatibility (2919); Difficult to Advance (2920); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/09/2023

Event Type  malfunction  

Event Description

It was reported that a versacross connect transseptal dilator was selected for use during a watchman case.Prior to the procedure, the mechanical guidewire was inserted inside the versacross dilator for test three times and it worked perfectly.Then, the mechanical guidewire was advanced into the versacross dilator, which was manually shaped to optimize the angle needed (the mechanical guidewire was inside the dilator).Then, at the beginning of the procedure, during initial groin access, once tracked up in patients anatomy, the mechanical guidewire was not able to either advance or withdraw from the versacross dilator.Therefore, both devices were removed and a new versacross kit was opened to be used (versacross rf wire from the first kit along with the new versacross dilator).No relevant information about the patient anatomy was noted.There is no reason to suspect the use of excessive force at the access site.The mechanical guidewire was removed from the patients body along with dilator, in one piece.The distal end of mechanical guidewire was protruding from the dilator.No damage to the dilator was noticed.The coil or either end of the coil were able to be stretched freely.No patient complications were reported.The procedure was completed successfully.The device is not expected to be returned for analysis.

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: 18074367
• MDR Text Key: 327417794
• Report Number: 2124215-2023-57866
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 00685447012597
• UDI-Public: 00685447012597
• 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: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: VMFI280623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1