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

Model Number	407439
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Codes	Air Embolism (1697); Arrhythmia (1721)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an atypical left atrial flutter procedure, an air leak occurred.After mapping the left atrium, the physician attempted to exchange the catheter for a tacticath se to begin ablation.Air entered the sheath during hd grid withdrawal but was immediately aspirated.Shortly after, the patient developed bradycardia and st elevation (displayed on all ecg leads), likely due to air entering the bloodstream.Sedation was paused to assess for neurological symptoms due to cerebral air ingress, but none were found.St elevation resolved within minutes, and ablation resumed using the tacticath after exchanging the sl1 sheath for an agilis.The procedure was then successfully completed.
Additional Manufacturer Narrative
Correction: h6.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One 8f swartz braided 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 seals were microscopically inspected.Tearing, resulting in a hole, was noted in the proximal and distal seals.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No nonconformances associated with the reported event were identified.The ifu states: do not remove dilator or catheter rapidly.Damage to the valve may occur, potentially compromising hemostasis.

• Brand Name: SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER SL 1 CURVE, 63 CM LENGTH, 8F
• 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 ; 6517565400
• MDR Report Key: 23097734
• Report Number: 3005334138-2025-00566
• Device Sequence Number: 9503948
• Product Code: DYB
• UDI-Device Identifier: 05414734205634
• UDI-Public: (01)05414734205634(10)10184704(17)261231
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 12/09/2025

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 Model Number: 407439
• Device Catalogue Number: 407439
• Device Lot Number: 10184704
• 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: 09/18/2025
• Supplement Date Received by Manufacturer: 10/27/2025; 12/09/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 11/26/2025; 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2024
• 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: Other
• Patient Sex: Unknown