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	08/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During the atrial fibrillation procedure, a cardiac tamponade requiring a thoracotomy was noted while performing left atrial mapping after transseptal puncture.Transseptal puncture was performed using a swartz sheath and rf needle.An hd grid catheter was inserted and left atrial mapping was being performed when the patients' blood pressure was noted to be dropping and a cardiac tamponade was confirmed via echocardiography.Hemostasis was achieved via a thoracotomy.The procedure was completed without replacing the device.The patient is stable and recovered.
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 tamponade requiring thoracotomy could not be conclusively determined.

• 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 ; +1(651)756-5400
• MDR Report Key: 50885527
• Report Number: 3005334138-2026-00489
• Device Sequence Number: 16119112
• Product Code: DYB
• UDI-Device Identifier: 05414734205757
• UDI-Public: (01)05414734205757(10)11351249(17)290331
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K052644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: 11351249
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2026
• 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