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

Lot Number VMFD290523

Device Problems Difficult to Remove (1528); Defective Device (2588); Component or Accessory Incompatibility (2897); Device-Device Incompatibility (2919); Material Deformation (2976); Material Integrity Problem (2978); Physical Resistance/Sticking (4012)

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

Event Date 08/23/2023

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 watchman laac procedure.An attempt to access superior vena cava utilizing mechanical guidewire has failed, since the physician was unable to advance the versacross dilator and the was sheath over the mechanical guidewire.Also, it could not retract it the mechanical guidewire from the versacross dilator, and a resistance was noticed when trying to withdraw wire from a non-boston scientific introducer sheath.Thus, it was needed to remove the entire system from patient's body, and then the mechanical guidewire was removed from the dilator (in one piece).The mechanical guidewire appeared to be severely kinked with coating possibly separating (seemed fractured/damaged), but in one piece.Hence, the verscross rf w wire was advanced into the patient's body with original dilator and sheath.Procedure continued as normal and was completed successfully.No patient complications were reported.The physician feel like the wire was getting caught while retracting, requiring it to pull with excessive force.The insulation of the mechanical guidewire was stripping off on the distal end.No patient complications occurred.The device is expected to be returned for analysis.

Manufacturer Narrative

This is supplemental mdr to report investigation results (mdr aware date 02nov2023).The device was returned for analysis.It was noted during analysis that the coil did not unfurl, the device is in one piece, kinks were noted at the floopy distal end of the wire and stacking of the external coil was present at the distal end of the wire.Also, it was noted that there is no notable kinks on the stiff section (wire body until proximal end, excluding distal floppy section) and various section exhibited section of coating loss.There were multiple locations exhibiting overlapping/misaligned coil, and multiple location with extensive, localized coating wear.

Event Description

It was reported that a versacross connect access solution was selected for use during a watchman laac procedure.An attempt to access superior vena cava utilizing mechanical guidewire has failed, since the physician was unable to advance the versacross dilator and the was sheath over the mechanical guidewire.Also, it could not retract it the mechanical guidewire from the versacross dilator, and a resistance was noticed when trying to withdraw wire from a non-boston scientific introducer sheath.Thus, it was needed to remove the entire system from patient's body, and then the mechanical guidewire was removed from the dilator (in one piece).The mechanical guidewire appeared to be severely kinked with coating possibly separating (seemed fractured/damaged), but in one piece.Hence, the verscross rf w wire was advanced into the patient's body with original dilator and sheath.Procedure continued as normal and was completed successfully.No patient complications were reported.The physician feel like the wire was getting caught while retracting, requiring it to pull with excessive force.The insulation of the mechanical guidewire was stripping off on the distal end.No patient complications occurred.The device is 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: 17775311
• MDR Text Key: 323753626
• Report Number: 2124215-2023-49406
• 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: 11/07/2023

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: VMFD290523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2023
• Initial Date FDA Received: 09/19/2023
• Supplement Dates Manufacturer Received: 11/02/2023
• Supplement Dates FDA Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male