MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, LAMP¿ 45, 63 CM LENGTH, 8.5F; INTRODUCER, CATHETER

Model Number	407362
Medical Device Problem Codes	Fracture (1260); Material Frayed (1262)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacture ref: 3005334138-2023-00539.During an atypical atrial flutter ablation procedure, a cut was noted on the sheath which required intervention from a vascular surgeon to extract the sheath properly from the right femoral vein.The procedure was interrupted with no consequences to the patient.
Additional Manufacturer Narrative
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 cut in the incident could not be confirmed.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One 8.5 swartz braided introducer was returned for analysis.However, the sheath was returned cut lengthwise in two pieces.Many bends were noted along the device.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported damage remains unknown.

• Brand Name: SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, LAMP¿ 45, 63 CM LENGTH, 8.5F
• 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: 18160131
• Report Number: 3005334138-2023-00540
• Device Sequence Number: 17803959
• Product Code: DYB
• UDI-Device Identifier: 05414734205573
• UDI-Public: 05414734205573
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/22/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Model Number: 407362
• Device Lot Number: 9155172
• 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: 11/10/2023
• Supplement Date Received by Manufacturer: 01/31/2024; 01/21/2025
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 02/01/2024; 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ADVISOR¿ HD GRID CATHETER, SE .
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown