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

Model Number 406948

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/20/2023

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 310279449
• Report Number: 3005334138-2023-00074
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734203531
• UDI-Public: 05414734203531
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K061015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 02/20/2023
• Initial Date FDA Received: 02/27/2023
• Supplement Dates Manufacturer Received: 04/12/2023
• Supplement Dates FDA Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention