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 Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During a heart catheterization, the sheath was placed in the right internal jugular vein.Two days post procedure, the patient complained of leaking iv fluids from the site.It was found that a portion of the introducer was no longer attached and bleeding was noted from the outlet hole.The site was covered and the catheter and introducer were removed from the patient.
Additional Manufacturer Narrative
Corrected information: g1.Additional information revealed the initial mdr for this event was reported under the incorrect mfr report # and manufacturing site.Corrected manufacturing site information has been provided in g1.The correct mfr number is 3005334138.
Additional Manufacturer Narrative
Additional information; g3, h2, h3, h6.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 material separation remains unknown.
Additional Manufacturer Narrative
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.

• Brand Name: FAST-CATH HEMOSTASIS INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer (Section G): ST. JUDE MEDICAL (CVD-PLYMOUTH); 5050 nathan lane north; plymouth MN 55442 2126
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20645597
• Report Number: 2182269-2024-00039
• Device Sequence Number: 12623173
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/10/2025

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
• Device Model Number: 406114
• Device Catalogue Number: 406114
• Device Lot Number: 10465562
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Supplement Date Received by Manufacturer: 01/03/2025; 01/28/2025; Not provided
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 01/03/2025; 01/28/2025; 02/10/2025
• 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: 53 YR
• Patient Sex: Male
• Patient Weight: 74 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White