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

Lot Number VLFC230423

Device Problems Device-Device Incompatibility (2919); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/06/2023

Event Type  malfunction  

Manufacturer Narrative

The device has been received for analysis, and upon completion of the failure analysis of the complaint device, the failure could not be reproduced, since a 0.035" versacross rf wire and mechanical j-wire were able to be backloaded and frontloaded into the device with no resistance during benchtop testing on the returned device.No evidence of dilator kinking or tip ovality was noted.However, a scuffing of the dilator curve, and also a minor tip defect outside of lumen (extra material) were noted during visual inspection.Thus, this initial mdr is being filed.If there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported that during the insertion of the mitra clip procedure to treat mitral valve, a versacross large access solution kit was selected for use.It has been mentioned that versacross dilator was not able to be front load with the versacross rf wire.The troubleshooting steps included back loading the dilator.The procedure was completed successfully by using another versacross kit.No patient complications have been reported.The product was expected to be returned.However, analysis of the device returned revealed a scuffing of the dilator curve, and a minor tip defect outside of lumen, extra material noted.

• Brand Name: VERSACROSS LARGE 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: 19106884
• MDR Text Key: 340821029
• Report Number: 2124215-2024-22626
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 00685447012535
• UDI-Public: 00685447012535
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K201288
• 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: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: VLFC230423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1