MAUDE Adverse Event Report: VERSACROSS RF WIRE; CATHETER, SEPTOSTOMY

Model Number	VXW-35-230-P
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient impact or consequence.Baylis medical company inc.Has decided to report this event due to the procedural delay that occurred.Dhr review was completed for the lot in question and the device fulfilled all requirements prior to release.
Event or Problem Description
A 20-minute procedural delay was reported in a case where the versacross rf wire caused an error code in the baylis radiofrequency perforation generator.The error code persisted after using another generator.The issue was resolved when another versacross rf wire was used for the procedure.While there was no patient injury reported, baylis medical company inc.Has decided to report this event due to the procedural delay.

• Brand Name: VERSACROSS RF WIRE
• Common Device Name: CATHETER, SEPTOSTOMY
• MDR Report Key: 12334121
• Report Number: 9710452-2021-00040
• Device Sequence Number: 4067875
• Product Code: DXF
• UDI-Device Identifier: 00685447003311
• UDI-Public: (01)00685447003311(17)240511(10)VXFA100521
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/17/2021

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 Expiration Date: 05/11/2024
• Device Model Number: VXW-35-230-P
• Device Lot Number: VXFA100521
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 08/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other