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

Model Number	VXSK0032
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
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 a versacross access solution was selected for use during a mitralclip procedure.During the case, it was noted that the coating on the wire was peeled off.Hence, the device was replaced, and the procedure was completed successful.No patient complications were reported.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, the wire coating damage was noted at the proximal end.Vhx inspections of the wire body confirmed the heat shrink has been damaged in two locations, at proximal end (rough cut) and a nick in the heat shrink.The device met its wire body outside diameter, electrode height and electrode/heat shrink gap inspection specifications.Based on the information provided in the complaint summary as well as based on the results of the testing/inspections performed, the reported allegations can be confirmed.
Event or Problem Description
It was reported that a versacross access solution was selected for use during a mitralclip procedure.During the case, it was noted that the coating on the wire was peeled off.Hence, the device was replaced, and the procedure was completed successful.No patient complications were reported.The device is expected to be returned for analysis.

• Brand Name: VERSACROSS ACCESS SOLUTION
• Common Device Name: CATHETER, SEPTOSTOMY
• 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: 20609368
• Report Number: 2124215-2024-69141
• Device Sequence Number: 7909407
• Product Code: DXF
• UDI-Device Identifier: 00685447017356
• UDI-Public: 00685447017356
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150709
• 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): 01/21/2025

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: 0034245936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 12/31/2024
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown