MAUDE Adverse Event Report: ST. JUDE MEDICAL ENGAGE INTRODUCER; INTRODUCER, CATHETER

Model Number	C408509
Medical Device Problem Codes	Fracture (1260); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During a redo typical flutter procedure, the advisor hd grid became entangled in the patient anatomy requiring surgical removal of the device.After positioning the coronary sinus catheter, the advisor hd grid catheter was placed inside the patient and mapping began in the right atrium.The catheter was difficult to maneuver, became stuck, and attempts to remove the catheter from the engage introducer were unsuccessful.It was then attempted to remove both the catheter and introducer together, however only the introducer came out.Damage was then noted on the introducer.Another introducer was used, and the catheter was cut in half in an attempt to remove it, however it was unsuccessful.A vascular surgeon was then called in and removed the introducer that was used for the coronary sinus catheter and the new introducer that was used to try to get the catheter out.This allowed the catheter to be removed.Upon removal, a red structure alleged to be a clot, or a small part of the vein could be seen.The procedure was then stopped with no further complications.Per the advisor hd grid catheter instructions for use, an 8.5f minimum introducer should be used.The engage introducer used is only an 8f.
Additional Manufacturer Narrative
One 8f engage introducer sheath was received for evaluation.The sheath distal tip had been split.The product instructions for use for the conjoined catheter warns to use a minimum 8.5f introducer.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the split tip and improper procedure is consistent with not following the instructions for use.

• Brand Name: ENGAGE INTRODUCER
• 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: 20787140
• Report Number: 3005334138-2024-00490
• Device Sequence Number: 20828323
• Product Code: DYB
• UDI-Device Identifier: 05414734053037
• UDI-Public: (01)05414734053037(10)10441262(17)270731
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K092575
• 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): 02/04/2025

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: C408509
• Device Catalogue Number: C408509
• Device Lot Number: 10441262
• 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: 11/08/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2024
• 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: ADVISOR HD GRID MAPPING CATHETER SE.
• Patient Sex: Unknown