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

Model Number	VXSK0031
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Handed off a versacross catheter for trans septal puncture and the generator didn't recognize the catheter indicating a defective wire.

• Brand Name: VERSACROSS ACCESS SOLUTION
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BAYLIS MÉDICALE CIE INC; 11320 route 9; champlain NY 12919
• MDR Report Key: 15492293
• Report Number: 15492293
• Device Sequence Number: 11234095
• Product Code: DYB
• UDI-Device Identifier: 00685447017349
• UDI-Public: (01)00685447017349
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/19/2022
• Report Date (Section F): 09/19/2022

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: VXSK0031
• Device Lot Number: VXFC170622
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/27/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/27/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/19/2022