MAUDE Adverse Event Report: ABBOTT MEDICAL TRICLIP¿ STEERABLE GUIDE CATHETER; TRICUSPID VALVE REPAIR DEVICE, PERCUTANEOUSLY DELIVERED

Model Number	TSGC0201
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2025, a patient presented with grade 5 functional tricuspid regurgitation (tr) for a triclip procedure.During the procedure, when trying to apply the minus on the triclip steerable guide catheter (tsgc), it would not work.It was noted that the sgc would turn but would not straighten.Device was replaced and continued the procedure.The final tr was grade 2.There were no adverse patient effects or clinically significant delays reported.
Additional Manufacturer Narrative
The device was not returned for analysis.The lot history record (lhr) and complaint history reviews were not performed as no lot or serial number was provided.Based on available information and the returned device analysis, the cause of the reported unable to straighten tsgc was unable to be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: TRICLIP¿ STEERABLE GUIDE CATHETER
• Common Device Name: TRICUSPID VALVE REPAIR DEVICE, PERCUTANEOUSLY DELIVERED
• 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: 24217096
• Report Number: 2135147-2026-00514
• Device Sequence Number: 15475237
• Product Code: DQY
• UDI-Device Identifier: 05415067047748
• UDI-Public: (01)05415067047748(17)260610(10)41210R1068
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K241538
• 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): 02/24/2026

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 Expiration Date: 06/10/2026
• Device Model Number: TSGC0201
• Device Catalogue Number: TSGC0201
• Device Lot Number: 41210R1068
• 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: 01/10/2026
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2024
• 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 Age: 70 YR
• Patient Sex: Male