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

Model Number	406107
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent a tavr procedure on (b)(6) 2025.While still admitted to the icu on (b)(6) 2025, it was observed that the pigtail that connects to the iv tubing broke off at the hub.The patient experienced some blood loss, but no treatment was required.The catheter was exchanged through the existing access site to resolve the issue.No other patient effects but the patient is still hospitalized.The line was not pulled or manipulated in any way.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One 7f fast-cath introducer sheath and dilator were received for evaluation.The extension tubing had detached from the sideport of the hemostasis body.A corrective action was initiated to investigate the failure mode of the sideport detachments.

• 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: 21664005
• Report Number: 3005334138-2025-00159
• Device Sequence Number: 15377259
• Product Code: DYB
• UDI-Device Identifier: 05414734013819
• UDI-Public: (01)05414734013819(10)10576720(17)270930
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 406107
• Device Catalogue Number: 406107
• Device Lot Number: 10576720
• 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: 02/28/2025
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown