MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIES 81 CM LE; Introducer, catheter

Model Number	406949
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 8f fast-cath introducer sheath and dilator were received for evaluation.Resistance was noted near the distal end of the dilator when a brk needle/stylet assembly from current inventory was advanced through the returned dilator and sheath.The dilator tubing was cut lengthwise and a build-up of skived material was noted at the distal end of the dilator.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the skiving remains unknown.
Event or Problem Description
This report is to advise of skiving that was noted during analysis.

• Brand Name: FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIES 81 CM LE
• 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 n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 21423469
• Report Number: 3005334138-2025-00100
• Device Sequence Number: 18090908
• Product Code: DYB
• UDI-Device Identifier: 05414734203548
• UDI-Public: (01)05414734203548(10)10102324(17)261031
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K982187
• 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
• Report Date (Section B): 02/20/2025

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 Model Number: 406949
• Device Catalogue Number: 406949
• Device Lot Number: 10102324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2025
• 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: 02/06/2025
• Initial Report FDA Received Date: 02/20/2025
• Date Device Manufactured: 11/29/2023
• 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