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

Lot Number	0034388631
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	08/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A pericardial effusion (pe) occurred, and the procedure was cancelled.It has been reported that a versacross access solution kit was selected for use for an atrial fibrillation (a fib) ablation.The transseptal puncture was performed successfully, and pulmonary vein isolation continued afterwards with the farawave catheter.Upon moving the intracardiac echocardiography (ice) catheter to view another heart structure a small pericardial effusion was observed that was not noted prior, located more on the right side of the heart.The farawave catheter was in the left atrium (la) at the time the effusion was located.The patient's vital were stable.Pericardiocentesis was performed and the procedure was cancelled before performing the planned posterior wall ablation.The patient was expected a fully recover and later discharged.The device is not expected to be returned for analysis (disposed).In the physician's opinion, it is possible that the pe occurred either during transseptal access or along with a non-boston scientific biosense webster "webster" cs catheter.Imaging was used to confirm the effusion.No malfunction was reported for the versacross devices.
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 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; zona franca la lima; cartago, 03 30106 ; CS 30106
• Manufacturer Contact: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20251188
• Report Number: 2124215-2024-58334
• Device Sequence Number: 8090091
• Product Code: DXF
• UDI-Device Identifier: 00685447011736
• UDI-Public: 00685447011736
• 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): 09/18/2024

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: 0034388631
• 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: 08/27/2024
• Initial Report FDA Received Date: 09/18/2024
• Date Device Manufactured: 04/15/2024
• 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
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Race: White