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	04/16/2026
Type of Reportable Event	Serious Injury
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 incident of a pericardial effusion could not be conclusively determined.
Event or Problem Description
During a paroxysmal atrial fibrillation procedure, a pericardial effusion was noted which resulted in a pericardiocentesis.The transseptal puncture was not easy.At the end of the pvi, the patient tension went from 10/7 to 50/3.The echo was checked and pericardial effusion was noted.Protamine was injected and the effusion was drained.800cc were drained and reinjected immediately into the patient.The tension increased to a normal value to 11/7 after drainage.The patient went to the icu and is recovering.The pvi was completed and successful.The physician alleges that the sheath dilator may have caused a minor scratch to the septum during the difficult transseptal puncture.There were no performance issues with any abbott 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 n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 25185562
• Report Number: 3005334138-2026-00233
• Device Sequence Number: 13425056
• Product Code: DYB
• UDI-Device Identifier: 05414734205757
• UDI-Public: (01)05414734205757(10)11242625(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): 05/15/2026

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: 11242625
• 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: 04/16/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2026
• 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