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

Lot Number VMFE061123

Device Problems Defective Device (2588); Device-Device Incompatibility (2919); Physical Resistance/Sticking (4012)

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

Event Date 01/18/2024

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 during a watchman procedure to treat atrial fibrillation (a fib) stroke prevention, a versacross connect kit was selected for use.The physician had an unusual experience while attempting to drag down with the versacross dilator/ radio frequency wire and watchman sheath.Both the dilator and wire were removed and upon inspection of the device, it was noted that the dilator tip was sliced down from the side.Hence to resolve the issue, the versacross kit was replaced and the procedure was completed successfully.No patient complications occurred.The device is expected to be returned for analysis.It was further confirmed that "wire" being referred was radio frequency wire.No damages noted to the guidewire or watchman sheath.The guidewire was able to advance/withdraw from the dilator.No material fragments noted.Resistance was felt.No anatomy issues noted.

Event Description

It was reported that during a watchman procedure to treat atrial fibrillation (a fib) stroke prevention, a versacross connect kit was selected for use.The physician had an unusual experience while attempting to drag down with the versacross dilator/ radio frequency wire and watchman sheath.Both the dilator and wire were removed and upon inspection of the device, it was noted that the dilator tip was sliced down from the side.Hence to resolve the issue, the versacross kit was replaced and the procedure was completed successfully.No patient complications occurred.The device is expected to be returned for analysis.It was further confirmed that "wire" being referred was radio frequency wire.No damages noted to the guidewire or watchman sheath.The guidewire was able to advance/withdraw from the dilator.No material fragments noted.Resistance was felt.No anatomy issues noted.

Manufacturer Narrative

Supplemental mdr is required to report investigation results.Mdr aware date 29apr2024.Upon receipt at our post market quality assurance laboratory, the returned versacross dilator was visually inspected which revealed a tearing of tip, a bending of the distal tip, a scuffing of the tip taper, side adjacent to the tip tear, and also a gross curvature of dilator.The benchtop analysis showed that using excessive force to pass a kinked versacross rf wire through the dilator could cause the tip to tear/split.Therefore, with all available information the complaint was confirmed, and the root cause for the dilator tip split was traced to the unintended use error.

• 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, 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: 18685754
• MDR Text Key: 335323730
• Report Number: 2124215-2024-07684
• Device Sequence Number: 1
• Product Code: DRE
• 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: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: VMFE061123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Male