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	Foreign Body In Patient (2687)
Date of Event	09/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During a transcatheter aortic valve implantation procedure, a sheath fracture occurred requiring surgical removal.A pacel bipolar pacing catheter (model #401766, lot #8906539) was placed through the patient's neck, using the introducer.It was then found that the sheath had fractured at the tip near the end of the procedure.After removing the components, the fractured sheath had to be surgically removed.The procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
One 6f fast-cath cath-lock introducer sheath was received for evaluation.The sheath hemostasis hub had been detached from the sheath tubing; the sheath hub was not returned.The proximal end of the sheath tubing had been fractured.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The reported issue is consistent with ep luer sheath hub detachment issues.

• 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: 17881359
• Report Number: 3005334138-2023-00456
• Device Sequence Number: 7770128
• Product Code: DYB
• UDI-Device Identifier: 05414734013772
• UDI-Public: 05414734013772
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 01/05/2024

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 Expiration Date: 02/28/2026
• Device Model Number: 406103
• Device Lot Number: 8952435
• 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: 10/04/2023
• Supplement Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female