MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS TRANSSEPTAL DILATOR; INTRODUCER, CATHETER

Device Problems Difficult to Remove (1528); Device-Device Incompatibility (2919); Material Deformation (2976); Physical Resistance/Sticking (4012)

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

Event Date 09/21/2023

Event Type  malfunction  

Event Description

It has been reported that a versacross steerable access solution kit has been selected for use for a watchman procedure indicated to treat a case of atrial fibrillation (a fib).During the procedure, the physician mentioned that the guidewire became stuck as it was being withdrawn from the dilator.The physician removed both the dilator and guidewire together from the patient and completed the procedure successfully using a new versacross kit (different device, different model).No patient complications reported.Product is expected to return for analysis.

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 has been reported that a versacross connect access solution has been selected for use for watchman procedure indicated to treat a case of atrial fibrillation (a fib).During the procedure, the physician mentioned that the guidewire became stuck as it was being withdrawn from the dilator.The physician removed both the dilator and guidewire together from the patient and completed the procedure successfully using a new versacross kit (different device, different model).No patient complications reported.Product is expected to return for analysis.It was further reported that the mechanical guidewire was exposed to the patient when it got stuck and also became kinked.No visible or anatomical issues were present.The dilator was slightly reshaped prior to use, as per usual.

Manufacturer Narrative

Due to additional information, the fields b5 (describe event or problem), d1 (brand name), d2a (common device name), d2b (pro code (product code)), f10, h6 (device codes) and g4 (premarket / 510(k) #) were updated, thus the supplemental medwatch is being field.The device has not been received for analysis yet.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.

• Brand Name: VERSACROSS TRANSSEPTAL DILATOR
• Type of Device: INTRODUCER, CATHETER
• 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: 17981295
• MDR Text Key: 326274887
• Report Number: 2124215-2023-57177
• Device Sequence Number: 1
• Product Code: DYB
• 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: 11/08/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1