MAUDE Adverse Event Report: ABBOTT MEDICAL TRICLIP¿ G5 STEERABLE GUIDE CATHETER; CATHETER, PERCUTANEOUS

Model Number	TSGC0801
Medical Device Problem Codes	Difficult to Insert (1316); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on 11 march 2026 that the patient presented with grade 5+ functional tricuspid regurgitation (tr) for a triclip procedure.During the procedure, triclip steerable guide catheter (tsgc) was unable to fit into stabilizer.Difficulty was encountered while removing stabilizer from tsgc.A replacement tsgc was used to complete the procedure.Two triclips were implanted to reduce the tr to grade 1+.There was no clinically significant delay or adverse patient effects reported.
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

• Brand Name: TRICLIP¿ G5 STEERABLE GUIDE CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 24769779
• Report Number: 2135147-2026-02106
• Device Sequence Number: 15764923
• Product Code: DQY
• UDI-Device Identifier: 05415067050724
• UDI-Public: (01)05415067050724(17)270607(10)51208R1003
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K243224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2026

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: TSGC0801
• Device Catalogue Number: TSGC0801
• Device Lot Number: 51208R1003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Supplement Date Received by Manufacturer: 05/31/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/08/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TRICLIP
• Patient Sex: Unknown