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

Lot Number VMFD290523

Device Problem Defective Device (2588)

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

Event Date 09/15/2023

Event Type  malfunction  

Manufacturer Narrative

The device has not 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.

Event Description

It was reported that during a watchman left atrial appendage closure (laac) procedure, a versacross connect kit was selected for use.Before the transseptal puncture, when the versacross dilator and watchman double curve sheath were prepared to advanced to atrial septum, the dilator hub broke off.Hence, both the sheath and dilator were removed and a new kit was opened.The transseptal puncture was performed successfully with the second kit.The procedure was completed successfully and no patient complications occurred.The device is expected to be returned for analysis.It was further confirmed no damages were noted to the dilator prior to removing it from the packaging or to the packaging itself.No unusual force applied.No fragments or separated pieces noted.The wire was inside the dilator at the time it snapped.The sheath was not found to be damaged or caused the dilator damage.

Event Description

It was reported that during a watchman left atrial appendage closure (laac) procedure, a versacross connect kit was selected for use.Before the transseptal puncture, when the versacross dilator and watchman double curve sheath were prepared to advanced to atrial septum, the dilator hub broke off.Hence, both the sheath and dilator were removed and a new kit was opened.The transseptal puncture was performed successfully with the second kit.The procedure was completed successfully and no patient complications occurred.The device is expected to be returned for analysis.It was further confirmed no damages were noted to the dilator prior to removing it from the packaging or to the packaging itself.No unusual force applied.No fragments or separated pieces noted.The wire was inside the dilator at the time it snapped.The sheath was not found to be damaged or caused the dilator damage.

Manufacturer Narrative

Supplemental report being submitted for the product analysis results.Bsc aware date is 02jan2024.A visual inspect found that there is a clean fracture of the hypotube, about 1 mm proximal to the proximal-end of the extrusion.Tip damage is confirmed to be due to the decontamination process and is not attributed to the complaint.No other issues noted: hypotube cross section has maintained ovality (i.E.No kinking) and there are no stress marks on the extrusion.Proximal end of device (i.E.Hub) was not returned for inspection.Evidence does not suggest that the hypotube fractured due to a kink.Reproducing the failure shows possibility of clean fracture is possible if the hypotube is damaged during manufacturing.This can take place during roll-cutting the extrusion.A weak local region on the hypotube, created by a sharp blade, would result in a clean fracture when torque/prying force is applied during the procedure.The difference in hypotube and extrusion length suggests that re-work was done to increase the hypotube protrusion length, after proximal trimming.Analysis of the returned product confirmed the dilator damage and the reported complaint.

• 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: 17980746
• MDR Text Key: 326310000
• Report Number: 2124215-2023-58090
• 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: 01/10/2024

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
• Date Returned to Manufacturer: 10/17/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2023
• Initial Date FDA Received: 10/20/2023
• Supplement Dates Manufacturer Received: 01/02/2024
• Supplement Dates FDA Received: 01/10/2024
• 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