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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 08/17/2023

Event Type  Injury  

Event Description

It was reported that there was a thrombus present and the procedure was cancelled.It was reported that a versacross connect access solution was selected for use during a left atrial appendage (laa) closure.The physician successfully performed the transseptal puncture (radio frequency applied once).The patient was given heparin post puncture, and the physician inserted the watchman system (was).It was noted while positioning the was that there was a thrombus that had formed on the sheath of the was (the act was therapeutic it was between 200-300).Thus, the physician aspirated the thrombus out of the patient, but they did not want to continue the procedure.The procedure was cancelled with no closure device implanted.The patient was admitted to hospital beyond standard care, fully recovered and it was discharged.The device is not expected to be returned for analysis (discarded).No difficulties were noted with completing the tsp.It was advised to the physician to give heparin pre and post transseptal, but it decided to just give it after transseptal.No other issues were reported.No act was taken pre procedure.It is unsure if in the physicians opinion, the transseptal devices had contributed to the adverse event.

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

• 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 L4W 5 P6; CA L4W 5P6
• Manufacturer Contact: timothy degroot degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17729766
• MDR Text Key: 323189416
• Report Number: 2124215-2023-49111
• 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: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2023
• Initial Date FDA Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 88 YR
• Patient Sex: Male