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

Model Number	TSGC0801
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2026, a patient presented for a triclip procedure.During the preparation, dilator was removed from the triclip steerable guide catheter (tsgc) packaging in a sterile field on the back table.Three-way stopcock was attached to the dilator flush port and while the distal tip of the dilator was under the surface of heparin saline in a basin on the table, dilator was flushed while closing the touhey valve.It was observed that tuohy valve on tsgc dilator has crack on it and leak was observed.Another tsgc was replaced and continued the procedure.There were no adverse patient effects or clinically significant delays reported.
Additional Manufacturer Narrative
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: 50098238
• Report Number: 2135147-2026-05207
• Device Sequence Number: 18734100
• Product Code: DQY
• UDI-Device Identifier: 05415067050724
• UDI-Public: (01)05415067050724(17)270914(10)60317R2075
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K243224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 08/28/2026

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 Model Number: TSGC0801
• Device Catalogue Number: TSGC0801
• Device Lot Number: 60317R2075
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2026
• Supplement Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 07/31/2026
• Supplement Report FDA Received Date: 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2026
• 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
• Patient Sex: Unknown