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
Event or Problem Description
During the atrial fibrillation procedure, the sheath was inserted into the right atrium.After inserting and removing the viewflex catheter into the sheath, blood began leaking from the hemostasis valve when inserting a 6f catheter.When the 6f catheter was removed from the sheath, the blood leak stopped, and the procedure was completed using the same 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.
Additional Manufacturer Narrative
One 8.5f fast-cath introducer sheath was received for evaluation.A dilator from current inventory was inserted and removed from the sheath.An aspiration vacuum leak test was conducted; no air aspirated into the syringe.A pressure leak test (liquid method) was also conducted; no leaks were noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported leak remains unknown.

• 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 north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22340090
• Report Number: 3005334138-2025-00386
• Device Sequence Number: 21113716
• 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,Followup
• Report Date (Section B): 07/23/2025

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?: 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: 06/04/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 07/23/2025
• 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: 89 YR
• Patient Sex: Female
• Patient Weight: 58 KG