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 Codes	Material Separation (1562); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One 8.5f swartz braided transseptal guiding introducer sheath was received for evaluation.Three photos were also received.The sideport tubing was cut at the sideport, and a small piece of tubing remained in the sideport.No stretching was noted on the sideport tubing.Functional leak testing was unable to be performed due to the aforementioned damage.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the device damage and reported leak remains unknown.
Event or Problem Description
During the af procedure, after the transseptal puncture, the guidwire was advanced through the sheath.It was then noted that there was a significant number of bubbles in the saline tube.It was then noted that the saline line had become disconnected from the junction.The sheath was exchanged, and the procedure was completed with no adverse consequences to the patient.

• 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 n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 25070681
• Report Number: 3005334138-2026-00236
• Device Sequence Number: 10407558
• Product Code: DYB
• UDI-Device Identifier: 05414734205771
• UDI-Public: (01)05414734205771(10)11133455(17)281031
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 07/15/2026

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: 11133455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2026
• 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: 04/07/2026
• Supplement Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 05/04/2026
• Supplement Report FDA Received Date: 07/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2025
• 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