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

Model Number	TSGC0801
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2026, a patient presented with functional tricuspid regurgitation (tr) for a triclip procedure.During device preparation, bubbles were identified when the triclip was inserted within the clip introduction.Troubleshooting was performed and the clip was readjusted, during which the clip became caught on the clip introducer and tore the device with the grippers.The tcds was removed from the patient and a replacement triclip was selected and successfully implanted.Two additional triclips were implanted successfully.The procedure was discontinued, the final tr was reduced.There were no adverse patient effects or clinically significant delays reported.
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 did not indicate product quality issue.Based on the available information, a cause for the reported air could not be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 50147285
• Report Number: 2135147-2026-05332
• Device Sequence Number: 18785864
• Product Code: DQY
• UDI-Device Identifier: 05415067050724
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2026

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: 60202R1067
• 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: 07/14/2026
• Supplement Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 08/05/2026
• Supplement Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2026
• 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