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

Model Number	TSGC0801
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	08/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2026 that the patient presented with grade 3+ functional tricuspid regurgitation (tr) for a triclip procedure.During the procedure, after removal of dilator loss of column and air were observed in hemostasis valve of triclip steerable guide catheter(tsgc).The tsgc was retracted into atrium.Aspiration was performed for removal of air.The loss of column was observed again.The tsgc was replaced with another device to complete the procedure.The tr was reduced to grade 1 post procedure.There was no clinically significant delay reported.
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.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: 50828612
• Report Number: 2135147-2026-06357
• Device Sequence Number: 8900809
• Product Code: DQY
• UDI-Device Identifier: 05415067050724
• UDI-Public: (01)05415067050724(17)270914(10)60317R2028
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 09/18/2026

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: 60317R2028
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Weight: 167 LB