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

Device Problem Difficult to Advance (2920)

Patient Problem Hematoma (1884)

Event Date 09/07/2022

Event Type  Injury  

Manufacturer Narrative

The device won't be returned for analysis.Upon evaluation of the failure analysis of the event reported, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported that a cardiac hematoma occurred.A left atrial appendage (laa) closure procedure was attempted using a 27mm watchman laa closure device with delivery system (wds) and a watchman fxd curve access system (was).A versacross connect laac access solution kit was selected for use during the transseptal puncture (tsp).The first and second attempts of radiofrequency (rf) crossing to complete a transseptal puncture (tsp) were unsuccessful.After the second attempt the rf needle slid superiorly.The third tsp was successful however the wire prolapsed and would not cross the septum.The wire was manipulated, and the septal cross was completed.Placement of the closure device was attempted requiring four device recaptures.It was determined the positioning difficulties resulted from the high location of the tsp.The was, wds, and closure device were all removed from the patient and also the sales representative confirmed that a tsp device was baylis versacross connect.After when a transesophageal echocardiogram (tee) was performed a hematoma was present in the left atrium adjacent to the laa on the posterior aspect of the heart.The laa closure procedure was discontinued.The patient was discharged four days post procedure.

• 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 ; CA
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17591883
• MDR Text Key: 321618518
• Report Number: 2124215-2023-44505
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: Yes
• 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: 07/27/2023
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Race: White