MAUDE Adverse Event Report: ST. JUDE MEDICAL ULTIMUM HEMOSTASIS INTRODUCER; CATHETER, INTRODUCER

Model Number	407849
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Type of Reportable Event	Malfunction
Event or Problem Description
During a right-sided procedure, there was a blood clot noted in the sheath.The sheath and dilator were prepped, and the side port was flushed.The sheath and catheter were placed in the femoral vein, but the sheath was not constantly irrigated with heparinized saline as routine practice.The procedure was completed with no adverse patient consequences.There is no further information available.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis; however, it was reported " the sheath was not constantly irrigated with herpanized saline as routine practice." the ultimum¿, ultimum¿ ev instructions for use (ifu) states: "flush the dilator(s), introducer sheath and infusion sideport and stopcock with heparinized normal saline.2.When a sideport introducer is used, follow normal practice of using a continuous drip of anticoagulant fluid under pressure through the sideport when the hemostasis introducer is in the vessel.¿ the device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported blood clot in the sheath could not be conclusively determined.

• Brand Name: ULTIMUM HEMOSTASIS INTRODUCER
• Common Device Name: CATHETER, INTRODUCER
• 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: 17607867
• Report Number: 3005334138-2023-00375
• Device Sequence Number: 17718920
• Product Code: DYB
• UDI-Device Identifier: 05414734011099
• UDI-Public: 05414734011099
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K031137
• 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): 11/15/2023

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: 12/31/2025
• Device Model Number: 407849
• Device Lot Number: 8848653
• 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: 08/10/2023
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2023
• 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
• Patient Sex: Unknown