MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS CONNECT LAAC ACCESS SOLUTION; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Medical Device Problem Codes	Material Frayed (1262); Difficult to Remove (1528); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
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 an versacross access solution was selected watchman procedure.During insertion, the access was granted, and it was being tried to go up with the mechanical guidewire.However, the guidewire got stripped and stuck upon tentative to remove it from the dilator hub.Once the guidewire was removed, it was noted to be unraveling, it was fully retrieved from the patient anatomy, and it remained in one piece.Thus, a new versacross connect kit was opened, and the procedure was completed successfully.No patient complication was reported.The device is not returning for analysis as it was discarded in facility.
Event or Problem Description
It was reported that an versacross access solution was selected watchman procedure.During insertion, the access was granted, and it was being tried to go up with the mechanical guidewire.However, the guidewire got stripped and stuck upon tentative to remove it from the dilator hub.Once the guidewire was removed, it was noted to be unraveling, it was fully retrieved from the patient anatomy, and it remained in one piece.Thus, a new versacross connect kit was opened, and the procedure was completed successfully.No patient complication was reported.The device is not returning for analysis as it was discarded in facility.
Additional Manufacturer Narrative
The device was not returned for analysis.However, based on the media provided, the reported allegation was confirmed.If there is any further relevant information obtained, a supplemental medwatch will be filed.

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• 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: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20194665
• Report Number: 2124215-2024-56864
• Device Sequence Number: 7535506
• Product Code: DRE
• UDI-Device Identifier: 00685447012573
• UDI-Public: 00685447012573
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K220414
• 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): 10/04/2024

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
• 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: 08/22/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 10/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown