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

Model Number	VXAK0005
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528); Deformation Due to Compressive Stress (2889); Detachment of Device or Device Component (2907); Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that during a left atrial appendage closure (laac) procedure to treat atrial fibrillation (a fib).A versacross connect kit was selected for use.The physician gained access with j-wire into the superior vena cava (svc) for transseptal puncture.However, while pulling the wire out, it unraveled and was lodged at the tip of dilator.Physician pulled the wire and dilator out at the same time.Patient was stable.Hence, the physician used the pigtail wire to completed the procedure.No patient complications occurred.The device is expected to be returned for analysis.
Event or Problem Description
It was reported that during a left atrial appendage closure (laac) procedure to treat atrial fibrillation (a fib), a versacross connect kit was selected for use.The physician gained access with j-wire into the superior vena cava (svc) for transseptal puncture.However, while pulling the wire out, it unraveled and was lodged at the tip of dilator.Physician pulled the wire and dilator out at the same time.Patient was stable.Hence, the physician used the pigtail wire to completed the procedure.No patient complications occurred.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
The returned versacross connect guidewire was analyzed.The returned mechanical guidewire, mgw revealed bundling of the coil at the distal end, multiple kinks on the guidewire body along with significant coating loss.It is possible that the guidewire was kinked or damaged during preparation thus causing the dilator compatibility issue resulting into increased resistance when withdrawing the guidewire into the vxa dilator.This could have caused the bundling of coils on the distal end of the guidewire.The reported allegation is confirmed.The return product did exhibit minor deformation of the coil (unravelling effect) likely due to excessive force applied.The unravelling effect did not lead to failure of the mechanical guidewire's device integrity.The cause not established cause code was selected based on the information provided within the event description and investigation results on the returned product.
Additional Manufacturer Narrative
Correction to the supplemental follow up 1.Mdr in block(s) h6 device codes and h10 narrative.Supplemental report submitted for product analysis results.The returned mechanical guidewire was analyzed.Pre-decontamination results confirmed obvious kink on the guidewire.Post-decontamination results confirmed kink at 50 and 100 cm from distal tip.There was an excessive coating loss pointing toward excessive friction force being applied/developed during withdraw.The testing results confirmed the guidewire outer diameter measured to be within specification at proximal tip.The vhx image inspection confirms stacked coil on distal end and major coating loss in immediate proximity of the kinked location.The wire pass test indicates that no significant deformities/opalization on the hypotube exist as to prevent passing of a.035 inch guidewire.The reported allegation is 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 that during a left atrial appendage closure (laac) procedure to treat atrial fibrillation (a fib), a versacross connect kit was selected for use.The physician gained access with j-wire into the superior vena cava (svc) for transseptal puncture.However, while pulling the wire out, it unraveled and was lodged at the tip of dilator.Physician pulled the wire and dilator out at the same time.Patient was stable.Hence, the physician used the pigtail wire to completed the procedure.No patient complications occurred.The device is expected to be returned for analysis.

• 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, qc 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: 17280050
• Report Number: 2124215-2023-35418
• Device Sequence Number: 5173008
• Product Code: DRE
• UDI-Device Identifier: 00685447012580
• UDI-Public: 00685447012580
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 01/30/2024

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 Model Number: VXAK0005
• Device Lot Number: VMFC240323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 08/21/2023; 01/04/2024
• Initial Report FDA Received Date: 07/07/2023
• Supplement Report FDA Received Date: 09/14/2023; 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Sex: Unknown