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

Lot Number	VPFC091123
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2024
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 was reported that a versacross connect access solution was selected for use during an atrial fibrillation ablation.The versacross rf wire was removed after transeptal puncture and it was noted that the coated had been scrapped off the versacross rf wire but remained connected, no coating was missing.No patient complications were noted.The procedure was completed successfully.The device is not expected to be returned for analysis (disposed).The physician did not feel like the wire was getting caught while retracting, requiring them to pull with excessive force.The patient did not have any mechanical hardware (leads, etc) in their ra that the wire got caught in.The insulation peeling back at the distal end just proximal, but it was intact.No other accessory device was used with the versacross wire, aside from the versacross dilator.No other damage was noted.
Event or Problem Description
It was reported that a versacross connect access solution was selected for use during an atrial fibrillation ablation.The versacross rf wire was removed after transeptal puncture and it was noted that the coated had been scrapped off the versacross rf wire but remained connected, no coating was missing.No patient complications were noted.The procedure was completed successfully.The device is not expected to be returned for analysis (disposed).The physician did not feel like the wire was getting caught while retracting, requiring them to pull with excessive force.The patient did not have any mechanical hardware (leads, etc) in their ra that the wire got caught in.The insulation peeling back at the distal end just proximal, but it was intact.No other accessory device was used with the versacross wire, aside from the versacross dilator.No other damage was noted.
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.However, due to the media provided, the reported allegation is confirmed.Thus this supplemental mdr is being filed with investigation result (mdr aware date is 11feb2024).

• Brand Name: VERSACROSS CONNECT ACCESS SOLUTION FOR POLARSHEATH
• 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: 18656191
• Report Number: 2124215-2024-02839
• Device Sequence Number: 8240891
• Product Code: DXF
• UDI-Device Identifier: 00685447019008
• UDI-Public: 00685447019008
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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,Followup
• Report Date (Section B): 03/04/2024

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: VPFC091123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 02/11/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male