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

Model Number	407694
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturing ref: 3005334138-2024-00526, 3005334138-2024-00527, 3005334138-2024-00528, 3005334138-2024-00530.During the procedure, the introducer was inserted and the guide catheter could not be passed over the valve.Four additional introducers from the same lot were used which had the same issue.A non abbott introducer was used to complete the procedure with no consequences to the patient.
Additional Manufacturer Narrative
Additional information: g3, h2, h3, h6.The results of the investigation are inconclusive since the device was not returned for analysis.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 insertion difficulties and subsequent delay remains unknown.
Additional Manufacturer Narrative
One 6f ultimum hemostasis introducer sheath and dilator were received for evaluation.The guidewire assembly was also returned.The reported event of guidewire insertion difficulty could not be confirmed.No resistance or other functional anomalies were noted during guidewire insertion through the dilator.Both the dilator distal tip inside diameter and guidewire outside diameter measurements were within specifications.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported insertion difficulty remains unknown.

• Brand Name: ULTIMUM 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: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20883003
• Report Number: 3005334138-2024-00529
• Device Sequence Number: 7902329
• Product Code: DYB
• UDI-Device Identifier: 05414734054737
• UDI-Public: (01)05414734054737(10)8697618(17)250930
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• 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,Followup
• Report Date (Section B): 03/05/2026

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: 09/30/2025
• Device Model Number: 407694
• Device Catalogue Number: 407694
• Device Lot Number: 8697618
• 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: 11/19/2024
• Supplement Date Received by Manufacturer: 01/16/2025; 03/03/2026
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 01/17/2025; 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ULTIMUM HEMOSTASIS INTRODUCER X4.
• Patient Sex: Unknown