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

Lot Number VMFD260523

Device Problems Difficult to Remove (1528); 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 08/16/2023

Event Type  malfunction  

Event Description

It was reported that a versacross connect access solution was selected for use during a watchman procedure.The femoral groin access gained, along with a non-boston scientific introducer sheath (16 fr).Then, the mechanical guidewire was inserted into the femoral vein and anchored it in the superior vena cava.Once the versacross connect was loaded over the mechanical guidewire, a small bend was added, and it was inserted into the patient.Issues were noted while advancing the dilator over the mechanical guidewire, therefore the physician noted the mechanical guidewire was too tight for the dilator.It was felt that the dilator get stuck and an attempted to pull the mechanical guidewire out, which got stuck inside the dilator and it was unable to withdraw.The distal end of mechanical guidewire was protruding from the dilator.The mechanical guidewire was noted kinked.It seems that the guidewire was fully retrieved/recovered from patient anatomy (didn't look like a piece broke off).It does not seems that the coil or either end of the coil (if coil fractured) was able to be stretched freely.Hence, a second versacross connect kit was opened, which the physician mentioned the same mechanical guidewire tightness issue, however, it was used normally.No patient complications were reported.The procedure was completed successfully.The mechanical guidewire and dilator are expected to be returned for analysis.Additionally, nothing unusual with the patient anatomy was noted.The physician has mentioned that he noticed it in the past as well.The dilator was manually shaped prior to the insertion.No other issues were noted.

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.

• 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: 17726566
• MDR Text Key: 323167117
• Report Number: 2124215-2023-49073
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 00685447012597
• UDI-Public: 00685447012597
• 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
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: VMFD260523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Female