MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIES, SL1¿ 8.; INTRODUCER, CATHETER

Model Number	406849
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a radiofrequency ablation of supraventricular tachycardia, a blood leak was noted from the hemostasis valve.The guidewire was inserted after puncturing for femoral vein access.After inserting the atrial septal puncture sheath along the guidewire, the valve of the sheath was slowly leaking blood.The sheath was replaced and the procedure was completed with no adverse effects on the patient.
Additional Manufacturer Narrative
One fast-cath¿ transseptal guiding introducer swartz¿ sl transseptal series, sl1¿ 8.5f 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 in the sidewall of the seal.No visual anomalies were on the distal face of the seal.A corrective action was initiated to address the failure mode of this introducer leak.

• Brand Name: FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIES, SL1¿ 8.
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22115932
• Report Number: 3005334138-2025-00304
• Device Sequence Number: 4122859
• Product Code: DYB
• UDI-Device Identifier: 05414734203388
• UDI-Public: (01)05414734203388(10)10592067(17)271031
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 08/12/2025

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: 406849
• Device Catalogue Number: 406849
• Device Lot Number: 10592067
• 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: 05/30/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2024
• 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