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	06/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A video was submitted; no product was received.The returned video appears to show the leaking of blood-like substance from the fast-cath.Visual inspection was based solely upon a review of the video provided.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The damage to the introducer is consistent with leak; how or when this damage occurred remains unknown.The ifu states: do not remove dilator or catheter rapidly.Damage to the valve may occur, potentially compromising hemostasis.
Event or Problem Description
During the atrial fibrillation procedure, with the sheath in the right atrium, the viewflex catheter was inserted through the sheath and then removed.However, when inserting the 6f catheter into the sheath, blood began leaking from the hemostasis valve.The leak was managed with tape, and the procedure was continued.The procedure was completed without replacing the sheath and there were no adverse consequences to the patient.The hospital discarded the reported sheath.No air movement into the patient was confirmed.The only products inserted directly into the hemostasis valve were the included dilator, viewflex catheter and 6f catheter.There was no resistance when inserting the dilator.The sheath and dilator were integrated and inserted as per the instructions.

• 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: 22308426
• Report Number: 3005334138-2025-00371
• Device Sequence Number: 8705589
• 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): 06/23/2025

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: 06/04/2025
• Initial Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 85 YR
• Patient Sex: Male
• Patient Weight: 63 KG