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

Lot Number	VMFA050523
Medical Device Problem Codes	Difficult to Remove (1528); Device-Device Incompatibility (2919); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during a watchman procedure to treat risk of bleeding, a versacross connect kit was selected for use.The right femoral vein access was gained with the mechanical guidewire.The versacross dilator and watchman sheath were inserted and when the physician tried to remove the guidewire, the wire became stuck in the dilator and by pulling, it kinked.Both the dilator and guidewire were removed.To resolve the issue, a new kit was opened and the radio frequency wire was used instead.The procedure was completed successfully and no patient complications occurred.The device is expected to be returned for analysis.It was further confirmed via gfe (dated (b)(6) 2023) the guidewire tracked up into the patient anatomy in the superior vena cava (svc) but nothing relevant to patient anatomy that could have led this issue.No visible issues noted with the guidewire upon unpackaging.There was no excessive forced used.When inserting the transseptal system into the vena cava.The guidewire was inserted into the svc and the versacross connect dilator and was were inserted.They attempted to remove the guidewire to insert the versacross rf wire but were unable to remove it and was stuck in the dilator.The dilator/wire will be returned.
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
The returned mechanical guidewire and dilator were analyzed.The mechanical guidewire was returned in one piece.From visual inspection, it was noted that the coil did not unfurl.Kinks were present at the floppy distal end of the wire and at the proximal end.Stacking (misalignment) of the external coil were present at the distal end of the wire.There was outer diameter and high magnification imaging test conducted on the returned guidewire.The mechanical guidewire passed the outer diameter measurement test.During the high magnification imaging measurement test, it was observed multiple locations exhibiting overlapping/misaligned coil and extensive, localized coating wear.The reported allegation was confirmed.This product is part of the 97072033-fa epflex guidewire obstruction advisory commencement advisory for the j-tipped mechanical guidewires.
Event or Problem Description
It was reported during a watchman procedure to treat risk of bleeding, a versacross connect kit was selected for use.The right femoral vein access was gained with the mechanical guidewire.The versacross dilator and watchman sheath were inserted and when the physician tried to remove the guidewire, the wire became stuck in the dilator and by pulling, it kinked.Both the dilator and guidewire were removed.To resolve the issue, a new kit was opened and the radio frequency wire was used instead.The procedure was completed successfully and no patient complications occurred.The device is expected to be returned for analysis.It was further confirmed via gfe (dated 22sep2023) the guidewire tracked up into the patient anatomy in the superior vena cava (svc) but nothing relevant to patient anatomy that could have led this issue.No visible issues noted with the guidewire upon unpackaging.There was no excessive forced used.When inserting the transseptal system into the vena cava.The guidewire was inserted into the svc and the versacross connect dilator and was were inserted.They attempted to remove the guidewire to insert the versacross rf wire but were unable to remove it and was stuck in the dilator.The dilator/wire will be returned.
Event or Problem Description
It was reported during a watchman procedure to treat risk of bleeding, a versacross connect kit was selected for use.The right femoral vein access was gained with the mechanical guidewire.The versacross dilator and watchman sheath were inserted and when the physician tried to remove the guidewire, the wire became stuck in the dilator and by pulling, it kinked.Both the dilator and guidewire were removed.To resolve the issue, a new kit was opened and the radio frequency wire was used instead.The procedure was completed successfully and no patient complications occurred.The device is expected to be returned for analysis.It was further confirmed via gfe (dated 22sep2023) the guidewire tracked up into the patient anatomy in the superior vena cava (svc) but nothing relevant to patient anatomy that could have led this issue.No visible issues noted with the guidewire upon unpackaging.There was no excessive forced used.When inserting the transseptal system into the vena cava.The guidewire was inserted into the svc and the versacross connect dilator and was were inserted.They attempted to remove the guidewire to insert the versacross rf wire but were unable to remove it and was stuck in the dilator.The dilator/wire will be returned.
Additional Manufacturer Narrative
**udi related data quality updates only** this report is being filed as a correction in response to an fda request for the complete the unique identifier (udi) #.

• 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: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17947005
• Report Number: 2124215-2023-57438
• Device Sequence Number: 7777057
• Product Code: DRE
• UDI-Device Identifier: 00685447012566
• UDI-Public: (01)00685447012566(17)20250803(10)VMFA050523
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/25/2024

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: 08/03/2025
• Device Lot Number: VMFA050523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: 02/15/2024; 07/09/2024
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 03/13/2024; 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male