MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS STEERABLE ACCESS SOLUTION; CATHETER, SEPTOSTOMY

Lot Number	0034139545
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It has been reported that a versacross steerable access solution kit has been selected for use for a watchman flx procedure.During the procedure, when the physician was frontloading and advancing the versacross rf wire into the versacross dilator and steerable sheath, it felt tight and difficulty to advance it, thus had to apply excessive force.Therefore, a new wire was requested, and the procedure was completed successfully.No patient complications were reported.The device is not returning as it was disposed in the facility.Once the versacross rf wire was removed, it was noted to be bend/kink, most likely due to the forward pressure to advance it, when it was felt to be stuck.No issues were noted when withdrawing the versacross rf wire.

• Brand Name: VERSACROSS STEERABLE ACCESS SOLUTION
• 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): BOSTON SCIENTIFIC CORPORATION; 2775 matheson blvd east; mississauga, on L4W 4 P7; CA L4W 4P7
• Manufacturer Contact: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20359524
• Report Number: 2124215-2024-61872
• Device Sequence Number: 15452706
• Product Code: DXF
• UDI-Device Identifier: 00685447012078
• UDI-Public: 00685447012078
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/03/2024

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
• Device Lot Number: 0034139545
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 10/03/2024
• Date Device Manufactured: 04/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Female