MAUDE Adverse Event Report: ABBOTT MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL0¿, 81 CM LENGTH, 8.5F; INTRODUCER, CATHETER

Model Number	407452
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
During the transseptal puncture, the dilator and the sheath were punctured several times by the needle in the area of the curvature.Both the needle and the sheath were replaced.An agilis sheath was used which resolved the issue and the procedure was completed with no adverse patient consequences.
Additional Manufacturer Narrative
One 8.5f swartz braided introducer sheath and dilator were received for evaluation.The sheath and dilator had been perforated proximal to the distal tip.The dilator and sheath were flushed with fluid and the dilator was inserted into the sheath; no resistance or anomalies were noted.A needle/stylet assembly from current inventory was inserted and advanced through the dilator/sheath assembly; however, the needle could not advance past the location of the perforation.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the perforation remains unknown.

• Brand Name: SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL0¿, 81 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: 23824632
• Report Number: 3005334138-2025-00775
• Device Sequence Number: 13083315
• Product Code: DYB
• UDI-Device Identifier: 05414734205764
• UDI-Public: (01)05414734205764(10)10780603(17)280229
• 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
• Report Date (Section B): 03/05/2026

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: 407452
• Device Catalogue Number: 407452
• Device Lot Number: 10780603
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2025
• 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