MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ GUIDING INTRODUCER SWARTZ¿ SR SERIES, SR0¿ 8.5F; INTRODUCER, CATHETER

Model Number	406853
Medical Device Problem Codes	Material Puncture/Hole (1504); Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	08/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturing ref: 3005334138-2024-00352, 3008452825-2024-00488 during an atrial fibrillation procedure, the transseptal needle with stylet went through the introducer during transseptal puncture.The introducer was exchanged, however the same issue occurred.The procedure was then cancelled due to a thrombus noted in the left atrium.The thrombus was not present prior to the procedure.The physicians considered it a medical condition of the patient.The patient's neurological status was checked, and everything was stable at the end of the procedure.Patient's information (e.G.Age, weight, gender, ethnicity, race, patient's initials) cannot be handled by abbott in absence of patient's written consent as required by the personal data protection national legislation.National legislation prevents the recording of such information.A written consent has not been obtained in this case; therefore, this information is not available.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6, h11.One 8.5f fast-cath introducer sheath and dilator were received for evaluation.The dilator had been punctured.Functional testing with a brk needle was not performed because the complaint introducer is a swartz right sided (sr series) guiding introducer dilator, not a transseptal introducer dilator.For transseptal access with a brk needle, swartz left sided (sl series) transseptal guiding introducers are recommended.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported thrombus remains unknown.The cause of the brk needle insertion difficulties is consistent with the incorrect use of the device.

• Brand Name: FAST-CATH¿ GUIDING INTRODUCER SWARTZ¿ SR SERIES, SR0¿ 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: 20226966
• Report Number: 3005334138-2024-00353
• Device Sequence Number: 11639194
• Product Code: DYB
• UDI-Device Identifier: 05414734202985
• UDI-Public: (01)05414734202985(10)10275593(17)270331
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Report Date (Section B): 11/17/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 406853
• Device Catalogue Number: 406853
• Device Lot Number: 10275593
• 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: 08/23/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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: BRK-1¿ XS TRANSSEPTAL NEEDLE.; FAST-CATH SWARTZ¿ SR0.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown