MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIES 63 CM LE; INTRODUCER, CATHETER

Model Number	406948
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Air Embolism (1697); Cardiac Arrest (1762)
Date of Event	12/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation procedure, an air embolism occurred resulting in cardiac arrest which required emergency treatment to stabilize the patient.The introducer was inserted into the left atrium using the guidewire included with the septal puncture needle.When the guidewire for cryo was inserted into the sheath to replace the sheath, the patient's blood pressure dropped.Up to this point, the devices inserted into the left atrium were the sheath and the guidewire of a cryo catheter.Fluoroscopy confirmed a large amount of air in the left ventricle.Atrioventricular block occurred, followed by bradycardia and cardiac arrest.The procedure was stopped and emergency treatment was performed.The patient is stable and under observation in the icu.The sheath was used according to the ifu.The physician believes that the air entrainment may have been caused by performing the device exchange while the left atrial pressure was low.There were no reported performance issues with the introducer.
Event or Problem Description
This report includes an updated event description.During an atrial fibrillation procedure, an air embolism occurred resulting in cardiac arrest which required intubation and cpr to stabilize the patient.The introducer was inserted into the right atrium using the guidewire included with the introducer, then a septal puncture was performed, and it was positioned into the left atrium using the guidewire included with the introducer.The sheath was replaced with a non-abbott guidewire and sheath (medtronic) for cryo.When the guidewire was inserted into the sheath, the patient's blood pressure dropped.Up to this point, the devices inserted into the left atrium were the reported introducer and the guidewire of a sheath introducer for cryo.Fluoroscopy confirmed a large amount of air in the left ventricle.Atrioventricular block occurred, followed by bradycardia and cardiac arrest.Emergency treatment was performed.The patient stabilized and was placed under observation in the icu.The sheath was used according to the ifu.The physician believes that the air entrainment may have been caused by performing the device exchange while the left atrial pressure was low.A total of three device exchanges were performed.The patient has been discharged and is being followed up with monthly outpatient visits.At present, no higher brain dysfunction or other sequelae have been observed.There were no reported performance issues with the introducer.
Additional Manufacturer Narrative
Additional information: b5, g3, h2.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One 8f fast-cath introducer sheath and dilator were received for evaluation.Functional testing determined a leak was noted in the hemostasis valve.The cap was removed from the hemostasis hub and the hemostasis seal was microscopically inspected.Tearing was noted in the seal.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the torn seal and subsequent leak remains unknown.

• Brand Name: FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIES 63 CM LE
• 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: 21093701
• Report Number: 3005334138-2025-00012
• Device Sequence Number: 21026610
• Product Code: DYB
• UDI-Device Identifier: 05414734203531
• UDI-Public: (01)05414734203531(10)8974977(17)260331
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K982187
• 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,Followup
• Report Date (Section B): 03/06/2025

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: 03/31/2026
• Device Model Number: 406948
• Device Catalogue Number: 406948
• Device Lot Number: 8974977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/13/2024
• Supplement Date Received by Manufacturer: 01/08/2025; 02/26/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 01/28/2025; 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2023
• 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: Life Threatening; Required Intervention
• Patient Sex: Unknown