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

Lot Number VMFA050523

Device Problems Difficult to Remove (1528); Device-Device Incompatibility (2919); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/20/2023

Event Type  malfunction  

Event 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.

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.

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 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.

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Type of Device: 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
• MDR Text Key: 325939395
• Report Number: 2124215-2023-57438
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 00685447012566
• UDI-Public: 00685447012566
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/13/2024

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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 09/20/2023
• Initial Date FDA Received: 10/16/2023
• Supplement Dates Manufacturer Received: 02/15/2024
• Supplement Dates FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male