MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL4¿, 63 CM LENGTH, 8F; Introducer, catheter

Model Number	407446
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, it was noted that an introducer that was expired was used in a patient.
Additional Manufacturer Narrative
An event of an expired device being used was reported.The results of the investigation are inconclusive since the device was not returned for analysis.However, swartz¿ braided transseptal guiding introducer, sl4¿, 63 cm length, 8f batch number 8112327 expired on 31 jul 2024 which was prior to the reported event date of 25 nov 2024.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, including verification of the expiration date listed on the product label.Based on the information received, the cause of the reported incident could not be conclusively determined.The cause of the use of expired product is consistent with user error.

• Brand Name: SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL4¿, 63 CM LENGTH, 8F
• Common Device Name: Introducer, catheter
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL (AFD-PLYMOUTH); 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20914474
• Report Number: 3005334138-2024-00538
• Device Sequence Number: 18261752
• Product Code: DYB
• UDI-Device Identifier: 05414734205702
• UDI-Public: (01)05414734205702(10)8112327(17)240731
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K052644
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 12/12/2024

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
• Device Expiration Date: 07/31/2024
• Device Model Number: 407446
• Device Catalogue Number: 407446
• Device Lot Number: 8112327
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2021
• 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
• Patient Sex: Male