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 Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a supraventricular tachycardia procedure, the puncture needle would not pass through the sheath.The sheath was then removed, and the needle was attempted to pass through the sheath outside the body.During this, it was found that the puncture needle had punctured the sheath.The sheath and needle were replaced, and the procedure was successfully completed with no adverse patient consequences.Stylet was used, needle was not reshaped.
Additional Manufacturer Narrative
Additional information: one 8.5f fast-cath 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.The returned associated complaint needle/stylet assembly from 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 cause of the needle perforation remains unknown.

• 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: 22471008
• Report Number: 3005334138-2025-00425
• Device Sequence Number: 4096919
• Product Code: DYB
• UDI-Device Identifier: 05414734203388
• UDI-Public: (01)05414734203388(10)10604811(17)271031
• 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: 10604811
• 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: 06/17/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2024
• 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
• Patient Sex: Unknown