MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH HEMOSTASIS INTRODUCER; INTRODUCER, CATHETER

Model Number	406114
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event of sideport detachment could not be confirmed.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
The following event was received from a voluntary medwatch report: it was reported that following a heart catheterization procedure, the sideport detached from the introducer which was replaced to resolve the issue.The introducer had been placed in the patient's right internal jugular vein during a heart catheterization procedure.Three days later in the cardiac icu, the bedside rn discovered the sideport of the introducer had fallen off, which had vasopressor medications infusing through the port.The physician was notified, the device was removed, and an alternate central venous catheter was inserted along with new pulmonary artery (pa) catheter.
Additional Manufacturer Narrative
Additional information: b5, g3, h2.Mw5161958.
Event or Problem Description
Follow up report needed to include medwatch number received.
Additional Manufacturer Narrative
Additional information: b5, g3, h2.Corrected information: h6.
Event or Problem Description
This report includes an updated health impact code.
Additional Manufacturer Narrative
Additional information: b5, g3, h2.Corrected information: h6.
Event or Problem Description
This report includes an updated health impact code.

• Brand Name: FAST-CATH HEMOSTASIS INTRODUCER
• 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 n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20723324
• Report Number: 3005334138-2024-00488
• Device Sequence Number: 3757290
• Product Code: DYB
• UDI-Device Identifier: 05414734013932
• UDI-Public: (01)05414734013932(10)10465562(17)270731
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K914090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/03/2025

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: 406114
• Device Catalogue Number: 406114
• Device Lot Number: 10465562
• Was Device Available for Evaluation?: No
• 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: 10/25/2024
• Supplement Date Received by Manufacturer: 11/27/2024; 02/10/2025; 03/03/2025
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 12/04/2024; 02/10/2025; 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2024
• 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 Age: 77 YR
• Patient Sex: Male
• Patient Weight: 110 KG
• Patient Ethnicity: Non Hispanic