MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER SL 1 CURVE, 63 CM LENGTH, 8F; INTRODUCER, CATHETER

Model Number	407439
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Great Vessel Perforation (2152); Cardiac Perforation (2513)
Date of Event	08/22/2024
Type of Reportable Event	Death
Event or Problem Description
Related manufacturing reference: 3008452825-2024-00502.During a ventricular tachycardia procedure, a cardiac tamponade occurred and the patient expired.While performing the transseptal approach, the patient's blood pressure dropped from 110 to 40.An echocardiogram was done which identified a cardiac tamponade.A pericardiocentesis and transfusion were performed, a total of 1.5l was drained.During the pericardiocentesis, the patient went into cardiac arrest.Cardiac massage was done but was unsuccessful and the patient deceased.The physician believed that the aorta was perforated by the sheath and dilator during the transseptal approach.
Additional Manufacturer Narrative
Corrected data: b5, h2, h6.Additional information: d9, g3, h2, h3, h6.An event of cardiac tamponade and death was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
This report includes an updated device problem code.

• Brand Name: SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER SL 1 CURVE, 63 CM LENGTH, 8F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20136858
• Report Number: 3005334138-2024-00358
• Device Sequence Number: 3265139
• Product Code: DYB
• UDI-Device Identifier: 05414734205634
• UDI-Public: (01)05414734205634(10)9047115(17)260430
• 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,Followup
• Report Date (Section B): 09/24/2024

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 Expiration Date: 04/30/2026
• Device Model Number: 407439
• Device Catalogue Number: 407439
• Device Lot Number: 9047115
• 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: 08/23/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2023
• 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: Death
• Patient Sex: Unknown