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

Model Number	TSGC0801
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported difficult to remove.Additionally, a review of the complaint history identified similar complaints reported to this lot, and this device appears to be related to a potential product quality issue.The investigation determined that the reported difficult to remove may be related to a potential product quality issue.This complaint falls within the scope of an exception, as the complaint description and device code match the specific issue described in the exception.The issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.
Event or Problem Description
It was reported that on (b)(6) 2026, a patient presented with grade 4-5 functional tricuspid regurgitation (tr) for a triclip procedure.After completing the procedure, it was unable to remove the triclip steerable guide catheter (tsgc) from the stabilizer.Tsgc was removed from the patient when it was still attached to the stabilizer.After removing from the patient, it needed more force to pull tsgc from the stabilizer.All steps were followed as per ifu.The final tr was grade 1-2.There were no adverse patient effects or clinically significant delays reported.

• 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: 24653426
• Report Number: 2135147-2026-01801
• Device Sequence Number: 17574441
• Product Code: DQY
• UDI-Device Identifier: 05415067050724
• UDI-Public: (01)05415067050724(17)270430(10)51031R1052
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 03/20/2026

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: 51031R1052
• 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: 02/24/2026
• Initial Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2025
• 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: Male
• Patient Weight: 80 KG