MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS RF WIRE; CATHETER, SEPTOSTOMY

Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a transseptal puncture procedure, a versacross rf wire was selected for use.The physician tried to insert the versacross rf wire directly through the non-boston scientific syringe needle causing bending of the wire tip.Thus, the device was replaced, and the issue was resolved.Procedure was completed successfully.No patient complications were reported.The device is still on hospital facilities and the product will not return for analysis.It has been further mentioned that when the versacross rf wire was inserted directly into the non-boston scientific needle utilized for femoral access, it became stuck just after the tip of the non-boston scientific needle.The physician attempted to pull it out, but was unable to do so and therefore removed the versacross rf wire and needle altogether.Outside the patient's body, the physician was able to retract the versacross rf wire from the needle, and that's when the kink was noted.No other issues were noted.
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

• Brand Name: VERSACROSS RF WIRE
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BAYLIS MEDICAL COMPANY INC.; 5825 explorer drive; mississauga, on L4W 5 P6; CA L4W 5P6
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19226449
• Report Number: 2124215-2024-26594
• Device Sequence Number: 20906544
• Product Code: DXF
• UDI-Device Identifier: 00685447003311
• UDI-Public: 00685447003311
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/01/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown