MAUDE Adverse Event Report: ABBOTT MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL0¿, 63 CM LENGTH, 8.5 F; Introducer, catheter

Model Number	407451
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	05/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During an atrial fibrillation procedure, prior to the transseptal puncture, the echocardiography showed a pericardial effusion around the ventricles of the heart, requiring a pericardiocentesis.The first transseptal puncture was completed using a swartz sheath and brk needle.A second transseptal puncture was then performed using an agilis sheath and a tacticath se catheter, using echocardiography as guidance.Mapping of the left atrium was completed using an advisor hd grid catheter.Ablation was subsequently initiated with the tacticath se catheter at the ridge of the left pulmonary vein.Only anterior ablation lesions were delivered; no posterior ablation was performed.The patient then became hypotensive and the echocardiogram confirmed presence of the same pericardial effusion previously observed at the beginning of the procedure.Pericardial drainage was performed, resulting in the removal of a total of 300 ml of blood and patient remained stable when they left the room.As the pericardial effusion was noticed before the transseptal puncture and then before the left atrium access, the physician alleges that this tamponade could be caused by the guidewires when they were inserted in the right atrium.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported cardiac perforation could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL0¿, 63 CM LENGTH, 8.5 F
• Common Device Name: Introducer, catheter
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 25282937
• Report Number: 3005334138-2026-00271
• Device Sequence Number: 18533737
• Product Code: DYB
• UDI-Device Identifier: 05414734205757
• UDI-Public: (01)05414734205757(10)11277376(17)290131
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K052644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/26/2026

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 Model Number: 407451
• Device Catalogue Number: 407451
• Device Lot Number: 11277376
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown