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

Model Number	406362
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At the end of an atrial fibrillation ablation procedure, a section of the device detached which led to abdominal embolization.Intervention was required to retrieve the detached portion.
Additional Manufacturer Narrative
One 8f fast-cath introducer sheath was received for evaluation.The sheath tubing had been torn and stretched into two sections; both sections were returned.The distal section of the sheath tubing had been torn and stretched 4.41¿ proximal to the distal tip.The proximal section had been torn and stretched at 0.45¿ distal to the distal end of the hemostasis hub; the proximal section remained attached to the hemostasis hub.There were multiple bends and kinks throughout the distal sheath tubing section; portions of the tubing had been flattened and kinked.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the material separation and subsequent embolism remains unknown.
Event or Problem Description
At the end of an atrial fibrillation ablation procedure, a section of the device detached which led to abdominal embolization.Intervention was required to retrieve the detached portion and the patient is doing well.

• 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: 17512780
• Report Number: 3005334138-2023-00353
• Device Sequence Number: 18128546
• Product Code: DYB
• UDI-Device Identifier: 05414734023412
• UDI-Public: 05414734023412
• 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
• Report Date (Section B): 09/06/2023

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
• Device Expiration Date: 06/30/2025
• Device Model Number: 406362
• Device Lot Number: 8568712
• 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: 08/09/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2022
• 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: Other
• Patient Sex: Unknown