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

Model Number	407834
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 8f ultimum introducer sheath was received for evaluation.The dilator and guidewire assembly were also received.The sheath passed pressure and aspiration leak testing with no anomalies observed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported leak remains unknown.
Event or Problem Description
During the percutaneous transluminal coronary angioplasty procedure, an air leak and a blood leak was noted.The introducer was replaced with no adverse consequences to the patient.The sheath was used for the puncture and blood-return was confirmed.When the side port with the three-way stopcock was used, there was air leakage noted from it and blood bleeding from the hub.The introducer was replaced to complete the procedure.Patient's condition was stable.
Additional Manufacturer Narrative
Corrected information: b5, d3, d4, g1, g3, h2.
Event or Problem Description
Follow up report needed to include corrected device manufacturer information.

• Brand Name: ULTIMUM HEMOSTASIS INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442 2126
• Manufacturer (Section G): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16459734
• Report Number: 2182269-2023-00005
• Device Sequence Number: 15081712
• Product Code: DYB
• UDI-Device Identifier: 05414734015974
• UDI-Public: (01)05414734015974(10)8360919(17)250131
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 10/16/2024

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: 01/31/2025
• Device Model Number: 407834
• Device Catalogue Number: 407834
• Device Lot Number: 8360919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2023
• 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: 02/17/2023
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• 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
• Patient Age: 45 YR
• Patient Sex: Male