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	03/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2026, a patient presented with tricuspid regurgitation (tr) for a triclip procedure.The procedure was completed successfully.After the procedure, it was difficult to remove the triclip steerable guide catheter (tsgc) from the stabilizer.Troubleshooting was performed, after significant force the sgc was removed from the stabilizer.The final tr was reduced.There were no adverse patient effects or clinically significant delays reported.
Additional Manufacturer Narrative
All available information was investigated, and the reported difficult to remove the tsgc from the stabilizer guide dock could not be replicated in a testing environment due to the returned condition of the device (damage pin hole of the guide attach).A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot-specific 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.

• 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: 24802120
• Report Number: 2135147-2026-02214
• Device Sequence Number: 10682161
• Product Code: DQY
• UDI-Device Identifier: 05415067050724
• UDI-Public: (01)05415067050724(17)270607(10)51208R1004
• 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
• Report Date (Section B): 04/07/2026

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: 51208R1004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: STABILIZER
• Patient Sex: Female