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

Model Number	TSGC0201
Medical Device Problem Codes	Leak/Splash (1354); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2026, a patient presented with grade 4 functional tricuspid regurgitation (tr) for a triclip procedure.During the procedure, first triclip was implanted.While placing the second clip on the leaflet, it was observed that a triclip steerable guide catheter (tsgc) would not hold the column and air was present in the device.Clip was implanted and the guide was removed from the patient.All steps were performed as per ifu.The final tr was grade 1.There were no adverse patient effects or clinically significant delays reported.
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) 2026, a patient presented with grade 4 functional tricuspid regurgitation (tr) for a triclip procedure.During the procedure, first triclip was implanted.While placing the second clip on the leaflet, it was observed that a triclip steerable guide catheter (tsgc) would not hold the column and air was present in the device.Clip was implanted and the guide was removed from the patient.All steps were performed as per ifu.The final tr was grade 1.There were no adverse patient effects or clinically significant delays reported.
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 event.Additionally, a review of the complaint history identified no other complaints from the lot.All available information was investigated and based on the information provided by the account and without the device to analyze, the cause for the reported leak and air/gas in the device cannot be determined.There is no indication of a product 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: 24652646
• Report Number: 2135147-2026-01797
• Device Sequence Number: 12259373
• Product Code: DQY
• UDI-Device Identifier: 05415067047748
• UDI-Public: (01)05415067047748(17)260805(10)50204R2028
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/27/2026

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: 08/05/2026
• Device Model Number: TSGC0201
• Device Catalogue Number: TSGC0201
• Device Lot Number: 50204R2028
• 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: 02/23/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2025
• 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