MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS STEERABLE ACCESS SOLUTION; CATHETER, SEPTOSTOMY

Lot Number	0033617115
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	06/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a pericardial effusion (pe) occurred.During an atrial fibrillation (a fib) ablation procedure, a versacross steerable kit was selected for use.The patient had a very thick septum causing difficulty to cross for transseptal access.Initially, there were three attempts to cross the septum made by the physician and then another physician as consulted.At this time, they chose to increase the radio frequency (rf) delivery of the versacross rf wire from 1 to 2 seconds/constant to accommodate for the thick septum.The fourth attempt was then successful.The patient remained stable throughout the entire procedure however later it was found to have a pericardial effusion upon the routine post procedural imaging.Hence, a pericardiocentesis was performed to address it.The patient left the lab in a stable state, was admitted for monitoring of the effusion, and it was later discharged in stable condition.The device is not expected to be returned for analysis (disposed).The procedure took about 3 hours in total where the transseptal access was obtained in around two hours.No issues with the versacross rf wire were noted during the first three attempts.The first three attempts were using 1 second/constant, and when rf was applied, the rf wire was advanced to attempt to cross the septum into the left atrium (la) but would stop mid-way through the septum due to its thickness.Various transseptal (tsp) locations were attempted in trying to locate a position for successful crossing, but all were within the mid-anterior to mid/inferior-anterior location.In the physician's opinion, there is no reason to believe any of the versacross device (rf wire or dilator/sheath) malfunctioned during the procedure, nor contributed to the patient's complication.
Additional 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 STEERABLE ACCESS SOLUTION
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2775 matheson blvd east; mississauga, on L4W 4 P7; CA L4W 4P7
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19609449
• Report Number: 2124215-2024-39045
• Device Sequence Number: 20863343
• Product Code: DXF
• UDI-Device Identifier: 00685447012122
• UDI-Public: 00685447012122
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K150709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/25/2024

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?: Yes
• Operator of Device: Health Professional
• Device Lot Number: 0033617115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 06/25/2024
• Date Device Manufactured: 02/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Sex: Male