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

Lot Number	VMFA150923
Medical Device Problem Codes	Difficult to Advance (2920); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a watchman procedure to treat gastrointestinal bleeding (gib), a versacross connect kit was selected for use.The physician attempted to insert the radio frequency wire into femoral access.It was noted that coating material around the pigtail shape was peeled back.There was difficulty noted in traverse inferior vena cava (ivc) which forced the physician to pull wire out and instantly notice the shearing.Hence to resolve the issue, the radio frequency wire was replaced and the procedure was completed successfully.No patient complications occurred.The device is not expected to be returned for analysis.It was further confirmed that the wire was not inserted through an introducer needle/cannula and no other damage noted on the wire before or after the insulation damage was discovered.
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.
Additional Manufacturer Narrative
Supplemental mdr aware date 15jan2024.The device was not returned, however, the reported allegation was confirmed through the picture provided in the complaint.
Event or Problem Description
It was reported that during a watchman procedure to treat gastrointestinal bleeding (gib), a versacross connect kit was selected for use.The physician attempted to insert the radio frequency wire into femoral access.It was noted that coating material around the pigtail shape was peeled back.There was difficulty noted in traverse inferior vena cava (ivc) which forced the physician to pull wire out and instantly notice the shearing.Hence to resolve the issue, the radio frequency wire was replaced and the procedure was completed successfully.No patient complications occurred.The device is not expected to be returned for analysis.It was further confirmed that the wire was not inserted through an introducer needle/cannula and no other damage noted on the wire before or after the insulation damage was discovered.

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal, qc 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: 18352864
• Report Number: 2124215-2023-71341
• Device Sequence Number: 15557536
• Product Code: DXF
• UDI-Device Identifier: 00685447012573
• UDI-Public: 00685447012573
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 02/05/2024

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 Expiration Date: 06/14/2026
• Device Lot Number: VMFA150923
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 01/15/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Female