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

Model Number	406350
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
At the end of an atrial fibrillation procedure, when the introducer positioned in the femoral vein was removed, it was noted that the 10 cm distal part was detached and remained in the vessel.A surgical procedure was needed to remove the detached piece with no adverse consequences.The procedure was extended by 20 minutes due to this incident.
Additional Manufacturer Narrative
One 5f fast-cath introducer sheath was received for evaluation.The sheath tubing had been torn and stretched into two sections; both sections were returned.There were multiple bends throughout the distal and proximal sheath tubing sections.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the sheath damage remains unknown.
Additional Manufacturer Narrative
Upon further review, the health impact code has been updated to f19 surgical intervention as surgery was required to remove the detached piece of the introducer from the patient.

• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17106329
• Report Number: 3005334138-2023-00260
• Device Sequence Number: 2773499
• Product Code: DYB
• UDI-Device Identifier: 05415067000767
• UDI-Public: 05415067000767
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 04/18/2024

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: 02/29/2024
• Device Model Number: 406350
• Device Catalogue Number: 406350
• Device Lot Number: 7869726
• 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: 06/01/2023
• Supplement Date Received by Manufacturer: 06/23/2023; Not provided
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 07/13/2023; 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2021
• 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