MAUDE Adverse Event Report: ABBOTT MEDICAL FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIES, SL1¿ 8.; INTRODUCER, CATHETER

Model Number	406849
Medical Device Problem Codes	Material Puncture/Hole (1504); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a supraventricular tachycardia procedure, the sheath was punctured when attempting to perform transseptal puncture.Puncture was attempted using a sheath, interatrial septum heartbeat, and needle.Repeated attempts did not break through the interatrial septum.It was found that the heart rate was a distorted and the sheath had a puncture.The needle was exchanged, and the interatrial septum was then crossed.The procedure was successfully completed with no adverse patient consequences.
Additional Manufacturer Narrative
One 8.5f fast-cath introducer sheath and dilator were received for evaluation.The dilator had been perforated proximal to the distal tip.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 device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The swartz/fast-cath transseptal guiding introducer instructions for use (ifu) states, ¿during insertion, always use the stylet to facilitate needle passage through the dilator/sheath assembly.Failure to use the stylet may inhibit advancement of the needle and may result in inadvertent needle puncture of the dilator/sheath assembly or skiving of material from the inner surface of the dilator.¿ the cause of the perforation is consistent with not following the instructions for use.

• Brand Name: FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIES, SL1¿ 8.
• 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: 22384436
• Report Number: 3005334138-2025-00413
• Device Sequence Number: 8818232
• Product Code: DYB
• UDI-Device Identifier: 05414734203388
• UDI-Public: (01)05414734203388(10)10106137(17)261031
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K061015
• 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): 07/28/2025

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: 406849
• Device Catalogue Number: 406849
• Device Lot Number: 10106137
• 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: 06/14/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2023
• 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
• Patient Sex: Unknown