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	06/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a pulmonary vein isolation procedure for atrial fibrillation, blood leaked from the hemostasis valve of the sheath.The sheath was replaced, however the same issue occurred.Due to it being at the end of the procedure, the procedure was completed without replacing the device again.There were no adverse patient consequences.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6, h11.One 10f fast-cath introducer sheath was received for evaluation.A dilator from current inventory was inserted and removed from the sheath.The sheath was tested for leaks.An aspiration vacuum leak test was conducted; air aspirated into the syringe.A pressure leak test (liquid method) was also conducted; water was noted to leak out of the hemostasis hub.The cap was removed from the hemostasis hub and the hemostasis seal was microscopically inspected.Tearing was noted on both sides of the seal.A corrective action was initiated to address the failure mode of this introducer leak.The ifu states: do not remove dilator or catheter rapidly.Damage to the valve may occur, potentially compromising hemostasis.

• 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: 22350379
• Report Number: 3005334138-2025-00391
• Device Sequence Number: 20992296
• 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): 08/25/2025

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: 06/18/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 08/25/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER
• Patient Sex: Male
• Patient Weight: 70 KG