MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. FAST-CATH; INTRODUCER, CATHETER

Model Number	406804
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Incident description: product never went in patient.The sheath was flushed and while advancing the dilator cardiovascular technologist (cvt) noted the dilator was deforming the curve and poking through the back-end.Replaced with another of same.Zero problem advancing the dilator.Notes from the ep procedure: three sheaths were inserted into the right femoral vein (rfv) (9,8,7fr) using ultrasound guidance.An 8fr intracardiac echocardiography catheter was inserted and advanced into the right atrium.Intracardiac echocardiography was performed which revealed normal lv function and no baseline pericardial effusion and was later used to guide the transseptal puncture.Notably the cavotricuspid isthmus (cti) anatomy was very curvilinear with a big pouch.A decapolar diagnostic catheter was advanced to the coronary sinus for left atrial pacing and recording.The cs was engaged but there was a prominent valve of vieussens and so a 4fr inquiry was tried.This too was unsuccessful.An 8.5fr mullens sheath was used for support and with the original bos sci decapolar through the mullens the valve or fenestration was crossed.Catheters/wires were advanced to the heart under fluoroscopic guidance.The right femoral venous 8fr sheath was exchanged over a wire for a medium curl agilis.

• Brand Name: FAST-CATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10436023
• Report Number: 10436023
• Device Sequence Number: 2714149
• Product Code: DYB
• UDI-Device Identifier: 05414734203302
• UDI-Public: (01)05414734203302(17)230131(10)7393690
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/06/2020
• Report Date (Section F): 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 406804
• Device Catalogue Number: 406804
• Device Lot Number: 7393690
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/21/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 77
• Date Report Sent to FDA: 08/17/2020