MAUDE Adverse Event Report: ABBOTT MEDICAL FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIES 63 CM LE; INTRODUCER, CATHETER

Model Number	406948
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the atrial fibrillation ablation procedure, when the sheath was inserted into the right atrium, the rv catheter (model: ibi-81521) was inserted into the sheath, after the septal puncture was performed and the ring catheter (a non-abbott product) was inserted, a blood leak was noted from the hemostasis valve.There was no movement of air into the patient¿s body.No additional venipuncture or septal puncture was performed when the introducer was replaced.No particular resistance was observed when a dilator was first inserted into the sheath hemostasis valve.The dilator was inserted into the sheath before insertion of the transseptal needle, and it was used correctly as per the procedure.The only devices inserted directly into the hemostasis valve were the included dilator, the rv catheter (model: ibi-81521), and the ring catheter (a non-abbott product).The sheath was replaced, and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, g6, h2, h3, h6, h11.One 8f fast-cath introducer sheath was received for evaluation.The sheath passed pressure and aspiration leak testing with no anomalies observed.The cap was removed from the hemostasis hub and the hemostasis seal was microscopically inspected.Tearing was noted on both sides of the seal.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the damaged seal remains unknown.

• Brand Name: FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIES 63 CM LE
• 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: 22229540
• Report Number: 3005334138-2025-00339
• Device Sequence Number: 8799502
• Product Code: DYB
• UDI-Device Identifier: 05414734203531
• UDI-Public: (01)05414734203531(10)10646890(17)271130
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K982187
• 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): 08/19/2025

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: 406948
• Device Catalogue Number: 406948
• Device Lot Number: 10646890
• 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: 06/12/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2024
• 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