MAUDE Adverse Event Report: BAYLIS MEDICALE CIE INC VersaCross Transseptal Sheath; Introducer, Catheter

Model Number	VXS85-35-63-45-D0
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
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.Good faith effort attempts to try and retrieve additional details regarding the reported event are in progress, but further information was unable to be obtained.If there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that versacross transseptal sheath was selected for use.During opening, it was realized the tap handle was broken and rendering the sheath unusable.The procedure was completed by using different device different model.No patient complication was reported.

• Brand Name: VersaCross Transseptal Sheath
• 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; multitenant #2, street #58 zon; cartago, 03 30106 ; CS 30106
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; +1(651)440-0979
• MDR Report Key: 24966153
• Report Number: 2124215-2026-22001
• Device Sequence Number: 10496135
• Product Code: DYB
• UDI-Device Identifier: 00685447003380
• UDI-Public: (01)00685447003380(17)271201(10)37249030
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K183655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/29/2026

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: VXS85-35-63-45-D0
• Device Catalogue Number: VXS85-35-63-45-D0
• Device Lot Number: 0037249030
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/01/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2026
• Supplement Date Received by Manufacturer: 05/11/2026; 07/14/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 06/03/2026; 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown