MAUDE Adverse Event Report: ABBOTT MEDICAL FAST-CATH¿TRIO INTRODUCER, 10F, ACT; INTRODUCER, CATHETER

Model Number	406963
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the atrial fibrillation procedure, when the non-abbott catheter (jll electrode catheter) was inserted, resistance was met and it could not be inserted.Upon inspecting the sheath, it was noted that the connector parts had broken off.There was no damage noted on the non-abbott catheter (jll electrode catheter).The introducer was replaced and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6, h11.One 10f fast-cath introducer sheath and trio hemostasis cap was received for evaluation.The trio hemostasis cap screwed onto the sheath with no anomalies.The trio hemostasis caps inside diameters were within specifications and no anomalies were noted when a guidewire from current inventory was inserted.No visual anomalies were noted on the returned device.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported events of the connector parts broke off remains unknown.

• Brand Name: FAST-CATH¿TRIO INTRODUCER, 10F, ACT
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23918752
• Report Number: 3005334138-2025-00790
• Device Sequence Number: 8763482
• Product Code: DYB
• UDI-Device Identifier: 05414734204057
• UDI-Public: (01)05414734204057(10)10856128(17)280430
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/13/2026

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: 406963
• Device Catalogue Number: 406963
• Device Lot Number: 10856128
• 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: 12/05/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2025
• 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