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

Model Number	SGC0801
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	08/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2026 that the patient presented with grade 4 functional mitral regurgitation (mr) for a mitraclip procedure.During the procedure, a mitraclip was successfully implanted.Following device deployment, echocardiography identified a thrombus at the tip of the steerable guide catheter (sgc).A guidewire was advanced through the sgc, and the sgc-dilator assembly was flushed until the thrombus was no longer evident.Heparin was administered.The sgc and dilator were subsequently advanced over the guidewire to facilitate implantation of a second clip.The patient remained hemodynamically stable throughout the procedure, and the thrombus was no longer visualized.The mr was reduced to grade <1 post procedure.There was no clinically significant delay 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.Based on the information reviewed, a cause for the reported thrombosis cannot be determined.The reported medication required was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: MitraClip¿ 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 Medical Northpoint Reg 3020950818; 1820 bastian court; westfield IN 46074
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; +1(651)756-5400
• MDR Report Key: 50873519
• Report Number: 2135147-2026-06441
• Device Sequence Number: 18470143
• Product Code: DQY
• UDI-Device Identifier: 05415067050908
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 09/23/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: SGC0801
• Device Catalogue Number: SGC0801
• Device Lot Number: 60515A1060
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2026
• 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: MitraClip
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown