MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL0¿, 81 CM LENGTH, 8.5F; INTRODUCER, CATHETER

Model Number	407452
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During the atrial fibrillation procedure, part of the sheath broke off from the device requiring surgical intervention to retrieve it.All pieces were accounted for with fluoroscopy.The physician cancelled the procedure due to the issue with the sheath.
Additional Manufacturer Narrative
One 8.5f swartz braided introducer sheath was received for evaluation.The sheath was noted to be fractured and detached from the distal end.Additionally, the distal half of the sheath was yellowed and noted to be cracked in multiple locations.The damage is consistent with degradation of the device due to exposure to uv light.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The product instructions for use (ifu) warns that the product should be stored in a cool, dark, dry place.The cause of the sheath degradation is consistent with not following the instructions for use.

• Brand Name: SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL0¿, 81 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 n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19825939
• Report Number: 3005334138-2024-00318
• Device Sequence Number: 8891954
• Product Code: DYB
• UDI-Device Identifier: 05414734205764
• UDI-Public: (01)05414734205764(10)8716844(17)250930
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: 407452
• Device Catalogue Number: 407452
• Device Lot Number: 8716844
• 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: 07/10/2024
• Supplement Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2022
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female