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

Lot Number VKFC160623

Device Problems Difficult to Remove (1528); Device-Device Incompatibility (2919); Difficult to Advance (2920)

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

Event Date 10/19/2023

Event Type  malfunction  

Event Description

It has been reported that a versacross steerable access solution kit was selected for use for an atrial fibrillation (a fib) ablation procedure.During the procedure, the physician mentioned that they experienced difficulty advancing the dilator/sheath over the guidewire.At a certain point, the dilator would not advance any further and could also not be withdrawn without significant resistance.The dilator and guidewire were removed together from the patient and a new kit was used (different device, same model).The procedure was then completed successfully and no patient complications reported.Product is not expected to return as it was retained by the customer.

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental will be filed.

• Brand Name: VERSACROSS STEERABLE 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: 18140267
• MDR Text Key: 328170456
• Report Number: 2124215-2023-64265
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00685447012078
• UDI-Public: 00685447012078
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190688
• 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: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: VKFC160623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1