MAUDE Adverse Event Report: ABBOTT MEDICAL FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SL SERIES, SL0¿ 10F; Introducer, catheter

Model Number	406968
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
During the atrial fibrillation ablation procedure, when the sheath was inserted into the right atrium and the viewflex catheter was inserted into the sheath, blood leakage was noted from the hemostasis valve.The sheath was replaced, and the procedure was completed with no adverse consequences to the patient.The hospital discarded the reported introducer.No air aspiration or entry into the patient¿s body was confirmed.The only devices inserted directly into the hemostasis valve were the included dilator and viewflex catheter.No additional venipuncture was performed when the introducer was replaced.No particular resistance was noted when the dilator was first inserted into the sheath hemostasis valve.The dilator was properly inserted into the sheath and used as per the procedure.

• Brand Name: FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SL SERIES, SL0¿ 10F
• 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: 22442441
• Report Number: 3005334138-2025-00417
• Device Sequence Number: 15321760
• Product Code: DYB
• UDI-Device Identifier: 05414734203562
• UDI-Public: (01)05414734203562(10)10729210(17)280131
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 07/08/2025

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: 406968
• Device Catalogue Number: 406968
• Device Lot Number: 10729210
• Was Device Available for Evaluation?: No
• 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: 07/03/2025
• Initial Report FDA Received Date: 07/08/2025
• Date Device Manufactured: 02/17/2025
• 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 Age: 63 YR
• Patient Sex: Unknown
• Patient Weight: 58 KG