MAUDE Adverse Event Report: BAYLIS MEDICALE CIE INC VERSACROSS ACCESS SOLUTION; INTRODUCER, CATHETER

Model Number	VXSK0032
Medical Device Problem Codes	Flushing Problem (1252); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that during atrial fibrillation ablation procedure, a versacross access solution kit was selected for use.The physician mentioned that upon trying to pre-map with another catheter in the sheath, there was a lot of air.An issue was noted with the sheath/valve opening and it would not allow to flush properly.Hence, the sheath was replaced with faradrive as the physician was planning on exchanging later in procedure.The procedure was completed successfully.No patient complications occurred.The device is not expected to be returned for analysis (disposed).There were no other device present in the sheath when bubbles were seen.It was attempted to aspirate the sheath, but this was the time why it was not flushing/aspirating.It is believed the valve was attempted to open and close to see if that would help.There was no damage to the luer.No air was noted in the patient.

• Brand Name: VERSACROSS ACCESS SOLUTION
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BAYLIS MEDICALE CIE INC; 5959 trans-canada highway; montreal H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; zona franca la lima; cartgo, 03 30106 ; CS 30106
• Manufacturer Contact: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20640177
• Report Number: 2124215-2024-70240
• Device Sequence Number: 18008300
• Product Code: DYB
• UDI-Device Identifier: 00685447017356
• UDI-Public: 00685447017356
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 11/08/2024

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 Model Number: VXSK0032
• Device Catalogue Number: VXSK0032
• Device Lot Number: 0034329677
• 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: 10/23/2024
• Initial Report FDA Received Date: 11/08/2024
• Date Device Manufactured: 04/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown