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

Model Number	VXW-35-230-P
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While there was no patient injury reported, baylis medical company inc.Has decided to report this event due to the 30-minute procedural delay.Dhr review was completed for the lot in question, and it was confirmed that all devices met relevant requirements prior to release.
Event or Problem Description
A 30-minute procedural delay was reported due to the buckling of the versacross rf wire coating.The procedure was continued after user manipulation to allow for the versacross transseptal sheath to be exchanged over the wire.After the transseptal access, the versacross rf wire was exchanged for a different wire for the remaining mitraclip 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: 11814363
• Report Number: 9710452-2021-00028
• Device Sequence Number: 11553689
• Product Code: DXF
• UDI-Device Identifier: 00685447003311
• UDI-Public: (01)00685447003311(17)231218(10)VXFB100321
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/12/2021

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: 12/18/2023
• Device Model Number: VXW-35-230-P
• Device Lot Number: VXFB100321
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 05/12/2021
• 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