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

Lot Number	0033754277
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	07/24/2024
Type of Reportable Event	Serious Injury
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.A separate problem report will be field for the versacross rf wire.
Event or Problem Description
It was reported a cardiac perforation, pericardial effusion followed by cardiac tamponade occurred.The procedure was cancelled.During a farapulse procedure, a versacross access solution kit was selected for use.The physician was attempting for transseptal, and the radio frequency (rf) was applied three times in order to note the rf bubbles in the left atrium (la) with intracardiac echocardiography (ice) guidance.There was a resistance felt with the versacross rf wire.Once the wire was in the la, it was noted to be kinked.Thus, a protrack wire was opened and inserted to exchange for the faradrive clear sheath.Once the faradrive catheter was inserted into the heart, a significant drop in blood pressure was noted and a pericardial effusion was noted on ice, located around the right ventricle.The procedure was aborted at this point, and an open-heart surgery was performed to close a puncture to the right atrium.The surgeon noted a puncture in the right atrium when the chest was open.The patient was admitted to hospital beyond standard of care and noted to be doing well after the surgery.The device is not expected to be returned for analysis (disposed).The anatomy was not difficult however there may have been a double layered fossa ovalis.The perforation occurred after rf was applied and the versacross rf wire was visualized in the la.There was no difficulty visualizing the wire, however difficulty noted visualizing the versacross sheath over the wire after rf energy was applied, due to technique.The pe was noted when exchanging the versacross sheath for the faradrive sheath.In the physician's opinion, the versacross sheath did not contribute to the adverse event.

• Brand Name: VERSACROSS ACCESS SOLUTION
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; zona franca la lima; cartgo, 03 30106 ; CS 30106
• Manufacturer Contact: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 19973586
• Report Number: 2124215-2024-50200
• Device Sequence Number: 7057378
• Product Code: DYB
• UDI-Device Identifier: 00685447011736
• UDI-Public: 00685447011736
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K183655
• 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): 08/13/2024

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?: No
• Operator of Device: Health Professional
• Device Lot Number: 0033754277
• 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: 07/24/2024
• Initial Report FDA Received Date: 08/13/2024
• Date Device Manufactured: 02/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Race: Asian