MAUDE Adverse Event Report: Abbott Medical TriClip¿ G5 Steerable Guide Catheter; Catheter, Percutaneous

Model Number	TSGC0801
Medical Device Problem Codes	Positioning Failure (1158); Difficult to Remove (1528)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	07/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a triclip procedure was performed to treat functional tricuspid regurgitation (tr) with a grade of 4 on patient with a restricted septal leaflet, prominent eustachian valve, and trileaflet.A triclip steerable guide catheter (sgc) (60420r1038) and a triclip xtw (50512r1005) clip delivery system (cds) were prepared per the instructions for use (ifu), inserted, and grasping was performed.However, difficulties with imaging occurred.After multiple grasping attempts, leaflet inserted was achieved.However, difficulties with imaging occurred, the leaflets were unable to be deeply seated in the clip arms, and difficulties with trajectory occurred.The cds was reset by removing ¿f ¿ knob and adding minus knob to be parallel with the intra-atrial septum of the superior vena cava (svc).However, a ¿membrane of some sort¿ was observed in the atrium.In the physician¿s opinion, the ¿membrane¿ was not chiari network.At this time, the sgc and the cds were at the original starting point, with the cds approximately 1 ½ inches away from the tip of the sgc.However, tension was encountered, and imaging revealed that the cds had retracted back to the sgc, and was lodged on the tip of the sgc.Troubleshooting was performed but was unsuccessful.Therefore, the sgc and the cds had to be removed together as one unit.The cds was closed completely down, and the sgc and cds were continued for removal as one unit.However, while approaching the femoral vein, it was noted that one of the cds clip arms canted open to approximately 5 degrees.An attempt was then made to close the clip arms tighter, without success.Therefore, vascular surgery was then performed to remove both the sgc and cds at the access point.The groin was preclosed with a preclosure device without further issues.The procedure was discontinued.The patient was reported to be stable throughout the procedure.
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.

• 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 ; +1(651)756-5400
• MDR Report Key: 50193810
• Report Number: 2135147-2026-05443
• Device Sequence Number: 9887173
• Product Code: DQY
• UDI-Device Identifier: 05415067050724
• UDI-Public: (01)05415067050724(17)271018(10)60420R1038
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,Followup
• Report Date (Section B): 09/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TSGC0801
• Device Catalogue Number: TSGC0801
• Device Lot Number: 60420R1038
• 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: 07/15/2026
• Supplement Date Received by Manufacturer: 09/25/2026
• Initial Report FDA Received Date: 08/10/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/20/2026
• 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 steerable guide catheter
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown