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

Model Number	406948
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During the atrial fibrillation procedure, the introducer got stuck in the femoral vein and broke apart.The lock tore and there was no resistance.The half of the introducer that was out of the patient was frayed on the end.The other half of the introducer was still in the patient's body, requiring vascular surgery for removal.A non-abbott merit medical snare was used and the other half of the introducer was successfully extracted.The introducer had several deformations due to the use of the one snare.There were no complications during the procedure and it was completed successfully.
Additional Manufacturer Narrative
One 8f fast-cath introducer sheath was received for evaluation.The sheath tubing had been torn and stretched into two sections.There were multiple bends and kinks throughout the distal and proximal sheath tubing sections.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the entrapment and sheath tubing damage 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16445877
• Report Number: 3005334138-2023-00074
• Device Sequence Number: 5844416
• Product Code: DYB
• UDI-Device Identifier: 05414734203531
• UDI-Public: 05414734203531
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 05/02/2023

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 Model Number: 406948
• Device Catalogue Number: 406948
• Device Lot Number: 8726190
• 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: 02/20/2023
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Other; Required Intervention
• Patient Sex: Unknown