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

Model Number	406103
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During a pacemaker implantation procedure, while inserting the sheath into a vein, the side port came off the sheath hub.The sheath was replaced and the procedure was completed with no adverse consequences to the patient.Air contamination to the patient has not been confirmed.No additional venipuncture was performed due to sheath replacement.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6, h11 one 6f fast-cath introducer sheath was received for evaluation.The reported event of sideport tubing detachment was confirmed.The extension tubing had detached from the sideport of the hemostasis body.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No nonconformances associated with the reported event were identified.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 north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20825637
• Report Number: 3005334138-2024-00513
• Device Sequence Number: 12720683
• Product Code: DYB
• UDI-Device Identifier: 05414734013772
• UDI-Public: (01)05414734013772(10)10274538(17)270228
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2025

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: 406103
• Device Catalogue Number: 406103
• Device Lot Number: 10274538
• 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: 11/25/2024
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2024
• 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