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

Lot Number VMFC300323

Device Problems Difficult to Remove (1528); Defective Device (2588); Device-Device Incompatibility (2919); Material Deformation (2976); Physical Resistance/Sticking (4012)

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

Event Date 07/03/2023

Event Type  malfunction  

Event Description

It was reported that a versacross connect access solution was selected for use during a watchman case.During the procedure, the mechanical guidewire was inserted into superior vena cava.Then, the versacross connect dilator snapped into watchman sheath and inserted over the mechanical guidewire into svc.Once trying to withdraw the mechanical guidewire to exchange it, it did not come off from the veracross dilator, since it was very tight.The physician felt like the mechanical guidewire was getting caught while withdrawing.Thus, the entire system was removed from the patient's body.Once out, the mechanical guidewire was with the insulation peeling back, and had been stripped off (at proximal end and distal end), and confirmed kinked.Therefore, the versacross kit was replaced.No patient complications were reported.The procedure was completed successfully.The devices are expected to be returned for analysis.

Manufacturer Narrative

The devices have 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

This is supplemental mdr to report investigation results (mdr aware date 11dec2023).The device was returned for analysis.The reported allegation was confirmed.It was noted during investigation that the mechanical guidewire (mgw) was stuck in the vxa dilator.The mgw remained in one piece, the external coil is not broken.However, the mgw core is fractured at the distal end, the distal j-shape is not maintained.The measurement of the mechanical guidewire outer diameter (mgw od) shows no feature notable deformation.It was revealed that the mgw od merriments are within drawing specifications.The mgw od near the proximal end, proximal to wire kink and distal to wire kink respectively.A significant coating loss can be noted along the mgw in proximity of wire kinks.The mgw wire pass test was performed on the vxa dilator revealing no difficulties in loading and withdrawing the mgw within the vxa dilator.Therefore, the hyptoube is not deformed.During high magnification imaging measurement, no sign of significant ovalization on the vxa dilator tip was noted, but it was noted the that the tip material from the vxa dilator is taken off by the mgw passing.Therefore, material build up can be expected within the lumen further restricting inner diameter during wire passage.It was noted that the lumen of the vxa dilator experienced material loss, the ro coil is not fully axially aligned, and the hypotube distal end does feature a chamfer and did not present an edge prone.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.During the procedure, the mechanical guidewire was inserted into superior vena cava.Then, the versacross connect dilator snapped into watchman sheath and inserted over the mechanical guidewire into svc.Once trying to withdraw the mechanical guidewire to exchange it, it did not come off from the veracross dilator, since it was very tight.The physician felt like the mechanical guidewire was getting caught while withdrawing.Thus, the entire system was removed from the patient's body.Once out, the mechanical guidewire was with the insulation peeling back, and had been stripped off (at proximal end and distal end), and confirmed kinked.Therefore, the versacross kit was replaced.No patient complications were reported.The procedure was completed successfully.The devices are expected to be returned for analysis.

• 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: 17400361
• MDR Text Key: 320238104
• Report Number: 2124215-2023-39276
• 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,Followup
• Report Date: 12/19/2023

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: VMFC300323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2023
• Initial Date FDA Received: 07/26/2023
• Supplement Dates Manufacturer Received: 12/11/2023
• Supplement Dates FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1