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

Lot Number	VXFA160823
Medical Device Problem Codes	Material Perforation (2205); Defective Device (2588); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during an atrial fibrillation (a fib) ablation procedure, a versacross access solution kit was selected for use.After opening the package, prior to inserting the device into the patient, the physician noted that the distal end of the dilator tip was damaged and bent nearly to the point which potentially could have fallen off.The tip almost seemed detachable or fragmented from the tip.The method of device removal from the packaging could have potentially caused the damage.Hence, the device was replaced, and the procedure was completed successfully.No patient complications occurred.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
The device has not been received for analysis yet.However, based on the media provided, the reported allegation for dilator tip damaged was confirmed.Thus, a supplemental mdr is being filed.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during an atrial fibrillation (a fib) ablation procedure, a versacross access solution kit was selected for use.After opening the package, prior to inserting the device into the patient, the physician noted that the distal end of the dilator tip was damaged and bent nearly to the point which potentially could have fallen off.The tip almost seemed detachable or fragmented from the tip.The method of device removal from the packaging could have potentially caused the damage.Hence, the device was replaced, and the procedure was completed successfully.No patient complications occurred.The device is expected to be returned for analysis.

• Brand Name: VERSACROSS ACCESS SOLUTION
• Common Device Name: 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: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 19459944
• Report Number: 2124215-2024-33895
• Device Sequence Number: 6653003
• Product Code: DYB
• UDI-Device Identifier: 00685447011729
• UDI-Public: 00685447011729
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K183655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2026
• Device Lot Number: VXFA160823
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2024
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 08/08/2024
• Date Device Manufactured: 08/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male