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

Lot Number VMFC310723

Device Problems Difficult to Insert (1316); 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 11/21/2023

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 laac - left atrium appendage closure.While advancing the versacross rf wire, it became kinked and stuck in patient.It could not be pulled system back.It was harder to push the wire through the dilator.However, it was finally able to pull it back.Once outside body noticed plastic piece had come off in one piece.No patient complications were reported.The procedure was completed successfully.The device is expected to be returned for analysis.The device was manually reshaped prior to the procedure.The damage to the device was noted when out of the body.The wire interacted only with the dilator during the procedure.The issue was observed once in the inferior vena cava.A resistance was experienced during insertion.It was mentioned that is was also tight when inserting it at the access site.The wire could not be removed from the dilator.The wire was protruding from the dilator.The wire was fully retrieved/recovered from patient anatomy.The defective wire remain in one piece.No other issues were noted.

Event Description

It was reported that a versacross connect access solution was selected for use during a laac - left atrium appendage closure.While advancing the versacross rf wire, it became kinked and stuck in patient.It could not be pulled system back.It was harder to push the wire through the dilator.However, it was finally able to pull it back.Once outside body noticed plastic piece had come off in one piece.No patient complications were reported.The procedure was completed successfully.The device is expected to be returned for analysis.The device was manually reshaped prior to the procedure.The damage to the device was noted when out of the body.The wire interacted only with the dilator during the procedure.The issue was observed once in the inferior vena cava.A resistance was experienced during insertion.It was mentioned that is was also tight when inserting it at the access site.The wire could not be removed from the dilator.The wire was protruding from the dilator.The wire was fully retrieved/recovered from patient anatomy.The defective wire remain in one piece.No other issues were noted.It was further confirmed (25jan2024) that the issue above is related to the mechanical guidewire and not with the versacross rf wire as initially reported.No issues were noted with the versacross rf wire.

Manufacturer Narrative

Due to additional information received on 25jan2024, the fields b5 (describe event or problem), d2a (common device name), d2b (pro code (product code), f10 and h6 (device codes (5) were updated.Thus, this supplemental report is being filed.The device has been received for 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.

Manufacturer Narrative

The returned mechanical guidewire was analyzed.The mechanical guidewire was returned in one piece.The vhx imaging test was performed on the returned guidewire and confirmed coil stacking, the test results were a fail.The device analysis confirmed the reported allegations.

Event Description

It was reported that a versacross connect access solution was selected for use during a laac - left atrium appendage closure.While advancing the versacross rf wire, it became kinked and stuck in patient.It could not be pulled system back.It was harder to push the wire through the dilator.However, it was finally able to pull it back.Once outside body noticed plastic piece had come off in one piece.No patient complications were reported.The procedure was completed successfully.The device is expected to be returned for analysis.The device was manually reshaped prior to the procedure.The damage to the device was noted when out of the body.The wire interacted only with the dilator during the procedure.The issue was observed once in the inferior vena cava.A resistance was experienced during insertion.It was mentioned that is was also tight when inserting it at the access site.The wire could not be removed from the dilator.The wire was protruding from the dilator.The wire was fully retrieved/recovered from patient anatomy.The defective wire remain in one piece.No other issues were noted.It was further confirmed (25jan2024) that the issue above is related to the mechanical guidewire and not with the versacross rf wire as initially reported.No issues were noted with the versacross rf wire.

• 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: 18308014
• MDR Text Key: 330937369
• Report Number: 2124215-2023-68785
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 00685447012580
• UDI-Public: 00685447012580
• 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: 03/19/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: VMFC310723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Race: White