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

Model Number VXAK0007

Device Problems Fracture (1260); Device-Device Incompatibility (2919); Difficult to Advance (2920); Material Integrity Problem (2978)

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

Event Date 06/07/2023

Event Type  malfunction  

Manufacturer Narrative

The devices have been received at boston scientific's post market laboratory where it is awaiting analysis.Upon 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 procedure to treat a left atrium appendage (laa) closure.The mechanical guidewire (mgw) was inserted into the groin access site, and the dilator was advanced over the mgw into the groin access area and a resistance near the inguinal area was noted.Then, the physician removed the versacross dilator and mechanical guidewire out of the patient's body and found the dilator tip had broken off and coiling and fracture were found on the mechanical guidewire.The devices were removed completely from the patient's body.Hence, a new versacross connect kit was opened and used.No patient complications were reported.The procedure was completed successfully.The devices have been received at boston scientific's post market laboratory where it is awaiting analysis.

Event Description

It was reported that a versacross connect access solution was selected for use during a watchman procedure to treat a left atrium appendage (laa) closure.The mechanical guidewire (mgw) was inserted into the groin access site, and the dilator was advanced over the mgw into the groin access area and a resistance near the inguinal area was noted.Then, the physician removed the versacross dilator and mechanical guidewire out of the patient's body and found the dilator tip had broken off and coiling and fracture were found on the mechanical guidewire.The devices were removed completely from the patient's body.Hence, a new versacross connect kit was opened and used.No patient complications were reported.The procedure was completed successfully.The devices have been received at boston scientific's post market laboratory.It has been further confirmed that the returned device failure mode match with the description and image provided by the customer.

Manufacturer Narrative

The fields b5 (describe event or problem); e4 (init rptr also sent rep to fda); f10 (device codes and component codes) were updated.The devices have been received at boston scientific's post market laboratory.Due to further investigation (24aug2023), a supplemental medwatch is being filed.Analysis of the returned products revealed that the tip cap had been detached from the dilator and caught on the mechanical guidewire.Visual inspection failed due to the fractured tip cap and unraveled ro-coil.Additionally, the mechanical guidewire (mgw) has been cut by the user, 80cm from kink location.Visual inspection confirms that a sharp tool has been used for cutting the distal end, rather than a tensile break.There is no evidence that the mgw has fractured due to the reported event.During benchtop testing, tip cap fracture with unused vxa-wm dilators and epflex guidewires was reproduced when the dilator was forced through an aggressive kink on the guidewire.Bending at the tip cap joint (i.E.Kink) can cause the joint to fracture.Furthermore, the resistance produced due to the guidewire kink causes the guidewire coils to overlap and the overall od of the guidewire to be no longer compatible with the dilator.Coil overlapping and loss of compatibility causes the dilator to catch on the guidewire.Likely procedural or anatomical factors encountered during procedure (provide facts e.G.Tortuosity) affected the device performance and its integrity.Device under tortuous condition due to patient anatomy or customer use/manipulation can cause the guidewire to bend/kink, and subsequent breaking of the dilator tip-cap joint.

• 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: 17218693
• MDR Text Key: 318070108
• Report Number: 2124215-2023-33605
• Device Sequence Number: 1
• Product Code: DRE
• 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
• Report Date: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VXAK0007
• Device Lot Number: VMFA050423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 80 YR