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

Model Number	VSTK0016
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
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.We are unable to provide the complete unique identifier (udi) at the time of the submission of this report, as it was not yet available.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during a pulse field ablation procedure, a versacross steerable access solution was selected for use.The physician performed transseptal puncture successfully and upon the device removal, it was noted that the sheath tip was damaged.There was a tear noted in the product.The physician completed the procedure, and no patient complications occurred.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
The device was returned for analysis.Upon receipt at our post market quality assurance laboratory, the steerable sheath was visually inspected and noted to have its distal tip teared and damaged.Next, the device passed functional test, as its handle was rotating properly, passed curve overlay and no damages to handle.Finally, the device has passed the dimensional test, as it was within specifications.The reported allegation was confirmed based on the returned product analysis.We are unable to provide the complete unique identifier (udi) at the time of the submission of this report, as it was not yet available.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during a pulse field ablation procedure, a versacross steerable access solution was selected for use.The physician performed transseptal puncture successfully and upon the device removal, it was noted that the sheath tip was damaged.There was a tear noted in the product.The physician completed the procedure, and no patient complications occurred.The device is expected to be returned for analysis.

• Brand Name: VERSACROSS STEERABLE 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; 2775 matheson blvd east; mississauga, on L4W 4 P7; CA L4W 4P7
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 21836720
• Report Number: 2124215-2025-23322
• Device Sequence Number: 18347403
• Product Code: DYB
• UDI-Device Identifier: 00685447007135
• UDI-Public: (01)00685447007135
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K190688
• 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): 06/19/2025

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: VSTK0016
• Device Catalogue Number: VSTK0016
• Device Lot Number: 0035345947
• 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: 03/25/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 04/14/2025
• Supplement Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown