MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH INTRODUCER; TROCAR

Model Number	G407209
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During the pulmonary vein isolation procedure, it was noted that while inserting the needle into the sheath, the needle did not go through the sheath cleanly, and a "scratching" feel was noted.The needle was replaced, and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported incident could not be conclusively determined.Model/lot number information was not able to be obtained for this device.Therefore, full udi information(d4) and 510k(g3) are not available.New information revealed that the reportable device for this event is the sl1 sheath.Give this, the manufacturing site number for this report is 3005334138.

• Brand Name: FAST-CATH INTRODUCER
• Common Device Name: TROCAR
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; edificio #44b, calle 0, avenida 2, coyol; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; edificio #44b, calle 0, avenida 2, coyol; plymouth MN 55442
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20226511
• Report Number: 3008452825-2024-00523
• Device Sequence Number: 19681331
• Product Code: DYB
• UDI-Device Identifier: 05414734205184
• UDI-Public: (01)05414734205184(10)10398727(17)270531
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2024

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: G407209
• Device Catalogue Number: G407209
• Device Lot Number: 10398727
• Was Device Available for Evaluation?: No
• 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: 09/02/2024
• Supplement Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 10/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2024
• 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
• Patient Sex: Unknown