MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ TRIO HEMOSTASIS INTRODUCER, CATH-LOCK¿ LOCKING HUB, 12 CM SHEATH, 12; INTRODUCER, CATHETER

Model Number	406306
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Hematoma (1884); Foreign Body In Patient (2687)
Date of Event	06/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During the atrial flutter and implantation of internal cardiac defibrillator system, upon removal of the right femoral venous sheath size 12fr, the distal portion tore from the proximal half.The distal portion of the sheath was retained within the femoral vein.The surgeon reported that he utilized the 3 port sheath system in the same fashion that he normally did.This time, when attempting to remove the sheath, it separated inside the vein.He had the team hold pressure at the site to keep the broken sheath piece from migrating.Vascular surgery came and removed the sheath in one piece and closed the vein.The patient tolerated the procedure without further complication.
Additional Manufacturer Narrative
The photos appeared to show one fast-cath introducer.The introducer shaft appeared to be fractured and detached.Visual inspection was based solely upon a review of the photographs provided.The device was not returned.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.
Additional Manufacturer Narrative
Additional information: g3, h2, h3, h6.Added code for the hematoma that occurred.

• Brand Name: FAST-CATH¿ TRIO HEMOSTASIS INTRODUCER, CATH-LOCK¿ LOCKING HUB, 12 CM SHEATH, 12
• 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: 16016182
• Report Number: 3005334138-2022-00692
• Device Sequence Number: 15123060
• Product Code: DYB
• UDI-Device Identifier: 05414734203920
• UDI-Public: 05414734203920
• Combination Product (Y/N): N
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: 406306
• Device Catalogue Number: 406306
• Device Lot Number: 8202175
• Was Device Available for Evaluation?: No
• 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: 11/25/2022
• Supplement Date Received by Manufacturer: 12/19/2022; 02/17/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 01/18/2023; 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 92 KG