MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿¿ GUIDING INTRODUCER SWARTZ¿ SR SERIES, SR0¿ 8.5F; INTRODUCER, CATHETER

Model Number	406853
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During a supraventricular tachycardia procedure, blood leaked from the hemostasis valve of the sheath after insertion.The sheath was replaced, and the procedure was successfully completed with no adverse patient consequences.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6, h11.One 8.5f fast-cath introducer sheath was received for evaluation.Functional testing determined an air leak was noted in the hemostasis valve.The cap was removed from the hemostasis hub and the hemostasis seal was microscopically inspected.A tear was noted in the distal face of the seal, at both ends of the seal slit.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the torn seal and subsequent leak remains unknown.The ifu states: do not remove dilator or catheter rapidly.Damage to the valve may occur, potentially compromising hemostasis.

• Brand Name: FAST-CATH¿¿ GUIDING INTRODUCER SWARTZ¿ SR SERIES, SR0¿ 8.5F
• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18969672
• Report Number: 3005334138-2024-00111
• Device Sequence Number: 20506736
• Product Code: DYB
• UDI-Device Identifier: 05414734202985
• UDI-Public: 05414734202985
• 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): 05/16/2024

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 Expiration Date: 03/31/2026
• Device Model Number: 406853
• Device Lot Number: 8996647
• 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: 03/06/2024
• Supplement Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2023
• 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