MAUDE Adverse Event Report: ABBOTT MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL1¿, 63 CM LENGTH, 8.5F; INTRODUCER, CATHETER

Model Number	407453
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a procedure, air was aspirated when the dilator was removed.The introducer was replaced and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6, h11.One 8.5f swartz braided introducer sheath was 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 ifu states: do not remove dilator or catheter rapidly.Damage to the valve may occur, potentially compromising hemostasis.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed.

• Brand Name: SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL1¿, 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 ; 6517565400
• MDR Report Key: 24282145
• Report Number: 3005334138-2026-00051
• Device Sequence Number: 9926873
• Product Code: DYB
• UDI-Device Identifier: 05414734205771
• UDI-Public: (01)05414734205771(10)10736322(17)280131
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 407453
• Device Catalogue Number: 407453
• Device Lot Number: 10736322
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2025
• 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
• Patient Sex: Unknown