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

Model Number VXAK0003

Device Problems Difficult to Remove (1528); Defective Device (2588); Component or Accessory Incompatibility (2897); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919); Difficult to Advance (2920); Material Deformation (2976); Physical Resistance/Sticking (4012)

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

Event Date 06/26/2023

Event Type  malfunction  

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.

Event Description

It was reported that a versacross connect access solution was selected for use during a watchman case to prevent stroke.During the procedure, the versacross connect was flushed and prepared as usual to obtain transeptal access.The mechanical guidewire was inserted into the rfv (right femoral vein) access sheath to pre wire into the superior vena cava (svc) before inserting versacross connect dilator with the watchman fxd sheath.The mechanical guidewire seemed to directed towards the hepatic vein and required multiple attempts to get into the svc, and once the mechanical guidewire was parked in the svc, the versacross connect was inserted over it.When attempting to remove the mechanical guidewire from the dilator, to exchange it for the versacross rf wire, the physician felt that the mechanical guidewire felt stuck.Thus, more force was applied to remove it, and the guidewire unraveled and snapped inside the dilator.Hence, the whole versacross system was removed entirely.It appears to be some distal kinks on the mechanical guidewire.Therefore, a new versacross was opened and used with no issues.No patient complications were reported.The procedure was completed successfully.The device is expected to be returned for analysis.

Manufacturer Narrative

The fields b5 'describe event or problem", "device codes" was updated based on additional information received.He 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.

Event Description

It was reported that a versacross connect access solution was selected for use during a watchman case to prevent stroke.During the procedure, the versacross connect was flushed and prepared as usual to obtain transeptal access.The mechanical guidewire was inserted into the rfv (right femoral vein) access sheath to pre wire into the superior vena cava (svc) before inserting versacross connect dilator with the watchman fxd sheath.The mechanical guidewire seemed to directed towards the hepatic vein and required multiple attempts to get into the svc, and once the mechanical guidewire was parked in the svc, the versacross connect was inserted over it.When attempting to remove the mechanical guidewire from the dilator, to exchange it for the versacross rf wire, the physician felt that the mechanical guidewire felt stuck.Thus, more force was applied to remove it, and the guidewire unraveled and snapped inside the dilator.Hence, the whole versacross system was removed entirely.It appears to be some distal kinks on the mechanical guidewire.Therefore, a new versacross was opened and used with no issues.No patient complications were reported.The procedure was completed successfully.The device is expected to be returned for analysis.On 21jul2023, it was further reported that the mechanical guidewire interacted with a non boston scientific venous access sheath.After the fact of the event, the pyshician said there was slight resistance when advancing the mechanical guidewire through the non-boston introducer sheath, a resistance was felt also when tracking the device through accessory devices.The mechanical guidewire was found in one piece, but portion of it unraveled.

Manufacturer Narrative

This is supplemental mdr to report the investigation results based on the pictures provided.The device yet did not return (mdr awareness date 04 dec2023).The reported allegations could be confirmed from the images provided.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.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 that a versacross connect access solution was selected for use during a watchman case to prevent stroke.During the procedure, the versacross connect was flushed and prepared as usual to obtain transeptal access.The mechanical guidewire was inserted into the rfv (right femoral vein) access sheath to pre wire into the superior vena cava (svc) before inserting versacross connect dilator with the watchman fxd sheath.The mechanical guidewire seemed to directed towards the hepatic vein and required multiple attempts to get into the svc, and once the mechanical guidewire was parked in the svc, the versacross connect was inserted over it.When attempting to remove the mechanical guidewire from the dilator, to exchange it for the versacross rf wire, the physician felt that the mechanical guidewire felt stuck.Thus, more force was applied to remove it, and the guidewire unraveled and snapped inside the dilator.Hence, the whole versacross system was removed entirely.It appears to be some distal kinks on the mechanical guidewire.Therefore, a new versacross was opened and used with no issues.No patient complications were reported.The procedure was completed successfully.The device is expected to be returned for analysis.On 21jul2023, it was further reported that the mechanical guidewire interacted with a non boston scientific venous access sheath.After the fact of the event, the pyshician said there was slight resistance when advancing the mechanical guidewire through the non-boston introducer sheath, a resistance was felt also when tracking the device through accessory devices.The mechanical guidewire was found in one piece, but portion of it unraveled.

• 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: 17344520
• MDR Text Key: 319752807
• Report Number: 2124215-2023-37029
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 00685447012573
• UDI-Public: 00685447012573
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VXAK0003
• Device Lot Number: VMFA100423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 74 YR