MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIES 63 CM LE; INTRODUCER, CATHETER

Model Number	406840
Medical Device Problem Codes	Flaked (1246); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation procedure, resistance was felt when the introducer was inserted in the patient.After removing the introducer, skiving was observed.The introducer was exchanged, and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h2, h3, h6, h11.One 8f fast-cath introducer sheath and dilator were received for evaluation.The sheath distal tip had been split.The dilator was inserted into the sheath and a gap was noted at the dilator/sheath transition, consistent with the aforementioned damage to the sheath distal tip.The dilator tubing was cut lengthwise; 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 fast-cath transseptal guiding introducer instructions for use (ifu) states, ¿during insertion, always use the stylet to facilitate needle passage through the dilator/sheath assembly.Failure to use the stylet may inhibit advancement of the needle and may result in inadvertent needle puncture of the dilator/sheath assembly or skiving of material from the inner surface of the dilator.¿ the cause of the skiving is consistent with not following the instructions for use.The cause of the sheath tip damage and patient insertion difficulty remains unknown.
Event or Problem Description
During an atrial fibrillation procedure, resistance was felt when the introducer was inserted in the patient.After removing the introducer, skiving was observed.The introducer was exchanged, and the procedure was completed with no adverse consequences to the patient.A stylet was not used, which goes against the introducer instructions for use.
Event or Problem Description
During an atrial fibrillation procedure, resistance was felt when the introducer was inserted in the patient while using a stylet.After removing the introducer, skiving was observed.The introducer was exchanged, and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h2, h3, h6, h11.One 8f fast-cath introducer sheath and dilator were received for evaluation.The sheath distal tip had been split.The dilator was inserted into the sheath and a gap was noted at the dilator/sheath transition, consistent with the aforementioned damage to the sheath distal tip and reported patient insertion issue.The dilator tubing was cut lengthwise; 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 sheath tip damage, patient insertion difficulty, and skiving remains unknown.

• Brand Name: FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIES 63 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 north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20703147
• Report Number: 3005334138-2024-00478
• Device Sequence Number: 8211346
• Product Code: DYB
• UDI-Device Identifier: 05414734203340
• UDI-Public: (01)05414734203340(10)9183619(17)260731
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K061015
• 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): 02/04/2025

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 Expiration Date: 07/31/2026
• Device Model Number: 406840
• Device Catalogue Number: 406840
• Device Lot Number: 9183619
• 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: 10/28/2024
• Supplement Date Received by Manufacturer: 01/08/2025; 02/23/2025
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 01/20/2025; 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2023
• 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 Age: 60 YR
• Patient Sex: Male
• Patient Weight: 60 KG