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

Model Number	TSGC0201
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received.However, investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported on (b)(6) 2025 that the patient presented with grade 5 functional tricuspid regurgitation (tr) and horizontal heart for a triclip procedure.During the procedure, imaging was difficult.First triclip was implanted successfully at anterior septal leaflet.During deployment of second triclip, difficulty was encountered while inserting clip over clip introducer.Troubleshooting was performed and was successful.Leaflets were grasped and the clip was deployed.First triclip was observed to be dislodged from anterior leaflet after deployment of second triclip.An attempt was made to retract the second triclip from the anatomy.Difficulty was encountered while retracting clip through steerable guide catheter(sgc) as both the grippers were unable to lower completely.A tissue was observed on the clip at the back table.The tr increased to grade 5 post procedure.Patient was in stable condition.There was no clinically significant delay.
Additional Manufacturer Narrative
All available information was investigated, and it was observed the soft tip was torn.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 identified no similar complaints reported from this lot.Based on available information and the returned device analysis, the observed torn soft tip was due to procedural circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported on (b)(6) 2025 that the patient presented with grade 5 functional tricuspid regurgitation (tr) and horizontal heart for a triclip procedure.During the procedure, imaging was difficult.First triclip was implanted successfully at anterior septal leaflet.During deployment of second triclip, difficulty was encountered while inserting clip over clip introducer.Troubleshooting was performed and was successful.Leaflets were grasped and the clip was deployed.First triclip was observed to be dislodged from anterior leaflet after deployment of second triclip.An attempt was made to retract the second triclip from the anatomy.Difficulty was encountered while retracting clip through steerable guide catheter(sgc) as both the grippers were unable to lower completely.A tissue was observed on the clip at the back table.The tr increased to grade 5 post procedure.Patient was in stable condition.There was no clinically significant delay.

• 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: 23501270
• Report Number: 2135147-2025-06502
• Device Sequence Number: 9048959
• Product Code: DQY
• UDI-Device Identifier: 05415067047748
• UDI-Public: (01)05415067047748(17)260707(10)50106R1097
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 12/17/2025

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: 07/07/2026
• Device Model Number: TSGC0201
• Device Catalogue Number: TSGC0201
• Device Lot Number: 50106R1097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2025
• 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; TRICLIP STEERABLE GUIDE CATHETER
• Patient Age: 86 YR
• Patient Sex: Male