MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL2¿, 63 CM LENGTH, 8.5 F; INTRODUCER, CATHETER

Model Number	407455
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During a left atrial appendage occlusion (laao) procedure, the sheath broke apart and remained in the patient, requiring medical intervention to remove the pieces.The sheath was being used to implant a watchman device.After transeptal access was achieved using the sheath and a brk-1 needle, a non-abbott (toray) guidewire was advanced into the left atrium through the sheath.The sheath was then removed to exchange for the watchman deployment sheath.When the sheath was removed from the patient, the device broke, cracking in several places.The tip of the device was also broken off, remaining in the patient, still on the guidewire.The tip was successfully retrieved using another sheath and a balloon and guided by fluoroscopy and ice.The sheath was replaced by an sl1, the procedure was then restarted and was completed with no adverse consequences to the patient.
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 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, SL2¿, 63 CM LENGTH, 8.5 F
• 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: 19937731
• Report Number: 3005334138-2024-00326
• Device Sequence Number: 7332328
• Product Code: DYB
• UDI-Device Identifier: 05414734205795
• UDI-Public: (01)05414734205795(10)8569139(17)250630
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/04/2024

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: 06/30/2025
• Device Model Number: 407455
• Device Catalogue Number: 407455
• Device Lot Number: 8569139
• 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: 07/16/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2022
• 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 Sex: Female