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

Model Number	TSGC0201
Medical Device Problem Codes	Positioning Failure (1158); Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 21 july 2025 that the patient presented with grade 4degenerative tricuspid regurgitation (tr) for a triclip procedure.During the procedure, while removing the clip delivery system post deployment of the clip, no resistance was felt while turning negative knob.The triclip steerable guide catheter(tsgc) was removed from the anatomy.The tsgc was replaced with another device to complete the procedure.The tr was reduced to grade <1 post procedure.At the back table, it was observed that resistance was felt while turning l knob and shaft was unable to curve.There was no clinically significant delay or adverse patient effects.
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 this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information and without the device to analyze, causes for the reported inability to straighten the tsgc and loose knobs could not be conclusively determined.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 4degenerative tricuspid regurgitation (tr) for a triclip procedure.During the procedure, while removing the clip delivery system post deployment of the clip, no resistance was felt while turning negative knob.The triclip steerable guide catheter(tsgc) was removed from the anatomy.The tsgc was replaced with another device to complete the procedure.The tr was reduced to grade <1 post procedure.At the back table, it was observed that resistance was felt while turning l knob and shaft was unable to curve.There was no clinically significant delay or adverse patient effects.No additional information was provided.

• 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: 23271483
• Report Number: 2135147-2025-05796
• Device Sequence Number: 9496281
• Product Code: DQY
• UDI-Device Identifier: 05415067047748
• UDI-Public: (01)05415067047748(17)260902(10)50305R1009
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 10/15/2025

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: 09/02/2026
• Device Model Number: TSGC0201
• Device Catalogue Number: TSGC0201
• Device Lot Number: 50305R1009
• 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: 07/22/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 10/10/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/05/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TRICLIP
• Patient Sex: Unknown