MAUDE Adverse Event Report: Abbott Medical Swartz¿ Braided Transseptal Guiding Introducer, LAMP¿ 45, 63 cm Length, 8.5F; Introducer, Catheter

Model Number	407362
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	07/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During the mitraclip procedure for mitral regurgitation, a pericardial effusion was noted after transseptal puncture with a brk needle and advancement of the swartz sheath.Transseptal puncture was performed with the brk needle and prior to inserting the mitraclip devices, a pericardial effusion was noted after advancing the sheath into the left atrium.When the pericardial effusion was noted, the patient experiences a drop in blood pressure.The procedure was stopped, and a pericardiocentesis was performed.An attempt was made to continue the mitraclip procedure; however, the patient was hemodynamically unstable and the physician preferred to remove the device and stop the procedure again.The patient was stable after the procedure and there were no further adverse patient health consequences.

• Brand Name: Swartz¿ Braided Transseptal Guiding Introducer, LAMP¿ 45, 63 cm Length, 8.5F
• 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: 50381149
• Report Number: 3005334138-2026-00433
• Device Sequence Number: 18589179
• Product Code: DYB
• UDI-Device Identifier: 05414734205573
• UDI-Public: (01)05414734205573(10)11234359(17)281231
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 08/21/2026

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: 407362
• Device Catalogue Number: 407362
• Device Lot Number: 11234359
• 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: Not provided
• Initial Report FDA Received Date: 08/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2026
• 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